SEARCH RESULTS FOR: 新聞總覽APP加固要多少钱(电报super4dog)ios超级签名.epd(2708 results)
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.
Kit contains: CONTOUR® NEXT ONE blood glucose meter; 10 CONTOUR® NEXT blood glucose test strips; Lancing Device; 10 Colored MICROLET® lancets (provided sterile); User Guide (including CONTOUR® DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT control solution. A clear endcap is available for Alternative Site Testing (AST). It may not be included in your meter kit. If you perform AST and need a clear endcap (for palm), contact Diabetes Care Customer Service.
ASCENSIA DIABETES CARE US INC.
9767
Not in Commercial Distribution
- 40301939767018 ()
- 00301939767010 ()
- 0193-9767-01 ()
85977059
- Glucose monitoring system IVD, home-use
BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.
BeCare Link, LLC
MS 2.1
In Commercial Distribution
- 00199284085701 ()
BCL-MS
- Self-care monitoring/reporting software
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
Steth IO
1.0
In Commercial Distribution
- 00860135001958 ()
- Electronic acoustic stethoscope
The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician.
The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viral-bacterial filter protecting the patient from the internal components of the device. The device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician’s computer via the STS software/App.
TECHNOPULM LTD
001
In Commercial Distribution
- 07290019579007 ()
STS-AS-1000
- Diagnostic spirometer, professional
- Pulmonary function analysis system, adult
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0065
In Commercial Distribution
- D83600650 ()
0065
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0064
In Commercial Distribution
- D83600640 ()
0064
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0063
In Commercial Distribution
- D83600630 ()
0063
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0062
In Commercial Distribution
- D83600620 ()
0062
- Dental composite resin
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that opehttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=create#rates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures.
The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery
FOTONA d.o.o.
M021-5AF/2 STAND
Not in Commercial Distribution
- 03830054230491 ()
- General/multiple surgical solid-state laser system
- Multi-modality skin surface treatment system generator
- Dermatological solid-state laser system
- Dental solid-state laser system
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood
pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace
self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202303OTC0 ()
- Self-care monitoring/reporting software
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood
pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace
self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202302OTC0 ()
- Self-care monitoring/reporting software
The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have
prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing.
The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP.
The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood
pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may
be used by people with diabetes and their HCP when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace
self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
In Commercial Distribution
- B553202301OTC0 ()
- Self-care monitoring/reporting software
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or forhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301830# hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188863 ()
- Pressure,30-40 mmHg
923CSSM99
- Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fithttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301826#ted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188849 ()
- Pressure,30-40 mmHg
923CMSM99
- Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301808#
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188832 ()
- Pressure,30-40 mmHg
923CLLM99
- Compression/pressure sock/stocking, single-use
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond.
It is designed with two functions.
1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs.
2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected.
It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution
- 00850023296023 ()
MyNotifi RX - small
- Bed/chair occupant movement pressure/vibration sensor
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond.
It is designed with two functions.
1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs.
2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected.
It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution
- 00850023296016 ()
MyNotifi RX - medium
- Bed/chair occupant movement pressure/vibration sensor
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond.
It is designed with two functions.
1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs.
2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected.
It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion du
MEDHAB, LLC
Version 2
In Commercial Distribution
- 00850023296009 ()
MyNotifi RX - large
- Bed/chair occupant movement pressure/vibration sensor
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS
In Commercial Distribution
- B786SBM1AA1100 ()
SBM1AA110
- Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution
- B786SBM1AA0170 ()
SBM1AA017
- Analgesic transcutaneous electrical nerve stimulation system