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No Description
Budget Hearing Aids, LLC
Atom X
In Commercial Distribution
- 00850065060880 ()
- Air-conduction hearing aid, canal
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The 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 healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
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. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes 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
Not in Commercial Distribution
- B553202258OTC0 ()
- Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The 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 healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
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. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes 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
Not in Commercial Distribution
- B553202257OTC0 ()
- Self-care monitoring/reporting software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202256RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202254RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202253OTC0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202252RX0 ()
- Home pharmaceutical management support software
Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202251OTC0 ()
- Home pharmaceutical management support software
No Description
Bausch & Lomb GmbH
E3305 X
In Commercial Distribution
- 04058935012045 ()
- Corneal scissors, reusable
No Description
Bausch & Lomb GmbH
E3839 X
In Commercial Distribution
- 04058935011659 ()
- Suturing needle holder, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXD2040
Not in Commercial Distribution
- 00851913006395 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXD2020
Not in Commercial Distribution
- 00851913006388 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXB50100
In Commercial Distribution
- 00851913006326 ()
- Transcutaneous electrical stimulation electrode, reusable
- Transcutaneous electrical stimulation electrode, single-use
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXB5050
In Commercial Distribution
- 00851913006319 ()
- Transcutaneous electrical stimulation electrode, reusable
- Transcutaneous electrical stimulation electrode, single-use
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXPB5000
Not in Commercial Distribution
- 00851913006234 ()
- Transcutaneous electrical stimulation electrode, single-use
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXF204
In Commercial Distribution
- 00851913006173 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXF202
In Commercial Distribution
- 00851913006166 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXF200
In Commercial Distribution
- 00851913006159 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXPB5010
Not in Commercial Distribution
- 00851913006043 ()
- Transcutaneous electrical stimulation electrode, single-use
No Description
AXELGAARD MANUFACTURING CO., LTD.
USXPB5050
Not in Commercial Distribution
- 00851913006036 ()
- Transcutaneous electrical stimulation electrode, single-use
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTXF50100
In Commercial Distribution
- 00851913006012 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX50100
In Commercial Distribution
- 00851913006005 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
Dermoscopy lens for camera devices (polarized, non-polarized, rechargeable, adjustable faceplate spacer)
DermLite LLC
DLFX
In Commercial Distribution
- 00855997006630 ()
DLFX
- Dermatoscope, optical
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX2020
In Commercial Distribution
- 00856817005291 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX2000
In Commercial Distribution
- 00856817005284 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX5050
In Commercial Distribution
- 00856817005277 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTX5000
In Commercial Distribution
- 00856817005260 ()
- Transcutaneous electrical stimulation electrode, single-use
- Transcutaneous electrical stimulation electrode, reusable
Gemini Vinyl/Nitrile Blend Exam Gloves Size XXL Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-XXL-1000
In Commercial Distribution
- 00850044884360 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size XL Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-XL-1000
In Commercial Distribution
- 00850044884353 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size L Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-L-1000
In Commercial Distribution
- 00850044884346 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size M Full Case
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-M-1000
In Commercial Distribution
- 00850044884339 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size XXL
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-XXL-100
In Commercial Distribution
- 00850044884322 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size XXL Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-XXL-2000
In Commercial Distribution
- 00850044884315 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size XL Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-XL-2000
In Commercial Distribution
- 00850044884308 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size L Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-L-2000
In Commercial Distribution
- 00850044884292 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size M Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-M-2000
In Commercial Distribution
- 00850044884285 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size S Full Case
Pacific Merchants Alliance LLC
N3-3-E-B-S-2000
In Commercial Distribution
- 00850044884230 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size XXL Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-XXL-1000
In Commercial Distribution
- 00850044884223 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size XL Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-XL-1000
In Commercial Distribution
- 00850044884216 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size L Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-L-1000
In Commercial Distribution
- 00850044884209 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size S Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-M-1000
In Commercial Distribution
- 00850044884193 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
X Factor Exam Grade Nitrile Gloves Size M Full Case
Pacific Merchants Alliance LLC
N2S-4-N-TXBU-M-1000
In Commercial Distribution
- 00850044884186 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size XXL
Pacific Merchants Alliance LLC
N3-3-E-B-XXL-200
In Commercial Distribution
- 00850044884162 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size S
Pacific Merchants Alliance LLC
N3-3-E-B-S-200
In Commercial Distribution
- 00850044884155 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size XL
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-XL-100
In Commercial Distribution
- 00850044884148 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size L
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-L-100
In Commercial Distribution
- 00850044884131 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Gemini Vinyl/Nitrile Blend Exam Gloves Size M
Pacific Merchants Alliance LLC
VN3E-5.5-MR-BU-M-100
In Commercial Distribution
- 00850044884124 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size XL
Pacific Merchants Alliance LLC
N3-3-E-B-XL-200
In Commercial Distribution
- 00850044884070 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size L
Pacific Merchants Alliance LLC
N3-3-E-B-L-200
In Commercial Distribution
- 00850044884063 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Dark Star Nitrile Exam Gloves Size M
Pacific Merchants Alliance LLC
N3-3-E-B-M-200
In Commercial Distribution
- 00850044884056 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial