SEARCH RESULTS FOR: 旺财超级签折扣常见安全问题-电报@Qianmingipa8‼️贷款app企业签名.lyz(3572 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Welldoc App for Diabetes in Pregnancy and Insulin Pump Users - B553202257OTC0

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
In Commercial Distribution

  • B553202257OTC0 ()


  • Self-care monitoring/reporting software

OtoNova Pro Screener AABR - 05060396173127

OtoNova Pro system for ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-A
In Commercial Distribution

  • 05060396173127 ()


  • Evoked-potential audiometer

OtoNova Pro Screener DP - 05060396173110

OtoNova Pro system for DPOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-D
In Commercial Distribution

  • 05060396173110 ()


  • Otoacoustic emission system, battery-powered

OtoNova Pro Screener TE - 05060396173103

OtoNova Pro system for TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-T
In Commercial Distribution

  • 05060396173103 ()


  • Otoacoustic emission system, battery-powered

Natural Cycles - 07350014630131

Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software

1st Choice, AMMEX Professional - 00819856022490

No Description
AMMEX CORPORATION
1ENVPFXLBX2
In Commercial Distribution

  • 00819856022490 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

1st Choice, AMMEX Professional - 00819856022483

No Description
AMMEX CORPORATION
1ENVPFLBX2
In Commercial Distribution

  • 00819856022483 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

1st Choice, AMMEX Professional - 00819856022476

No Description
AMMEX CORPORATION
1ENVPFMBX2
In Commercial Distribution

  • 00819856022476 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

1st Choice, AMMEX Professional - 00819856022469

No Description
AMMEX CORPORATION
1ENVPFSBX2
In Commercial Distribution

  • 00819856022469 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

1st Choice, AMMEX Professional - 10819856020486

No Description
AMMEX CORPORATION
1ENVPFXLCS2
In Commercial Distribution

  • 10819856020486 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

1st Choice, AMMEX Professional - 10819856020479

No Description
AMMEX CORPORATION
1ENVPFLCS2
In Commercial Distribution

  • 10819856020479 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

1st Choice, AMMEX Professional - 10819856020462

No Description
AMMEX CORPORATION
1ENVPFMCS2
In Commercial Distribution

  • 10819856020462 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

1st Choice, AMMEX Professional - 10819856020455

No Description
AMMEX CORPORATION
1ENVPFSCS2
In Commercial Distribution

  • 10819856020455 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
  • Vinyl examination/treatment glove, non-powdered

OtoNova Pro Clinical+AABR - 05060396173721

OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DA
In Commercial Distribution

  • 05060396173721 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

OtoNova Pro Clinical - 05060396173714

OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-D
In Commercial Distribution

  • 05060396173714 ()


  • Otoacoustic emission system, battery-powered

OtoNova Pro Clinical+TE - 05060396173486

OtoNova Pro system for Clinical OAE hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DT
In Commercial Distribution

  • 05060396173486 ()


  • Otoacoustic emission system, battery-powered

Kinesia - 00859584006164

Kinesia Web Application/Portal 2 Software
Great Lakes Neurotechnologies Inc.
360-2011, Kinesia Web App/Portal 2
In Commercial Distribution

  • 00859584006164 ()


  • Tremor transducer

Parky - 00860009869707

Parky App is a symptom tracker mobile app for Parkinson’s Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email.
H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI
V1
In Commercial Distribution

  • 00860009869707 ()


  • Tremor transducer

OtoNova Pro Clinical+TE+AABR - 05060396173172

OtoNova Pro system for Clinical OAE and ABR hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DTA
In Commercial Distribution

  • 05060396173172 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

OtoNova Pro Screener DP+AABR - 05060396173158

OtoNova Pro system for DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DA
In Commercial Distribution

  • 05060396173158 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

OtoNova Pro Screener TE+AABR - 05060396173141

OtoNova Pro system for TEOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-TA
In Commercial Distribution

  • 05060396173141 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

OtoNova Pro Screener DP+TE - 05060396173134

OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DT
In Commercial Distribution

  • 05060396173134 ()


  • Otoacoustic emission system, battery-powered

OtoNova Pro Screener DP+TE+AABR - 05060396173165

OtoNova Pro system for TEOAE, DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DPTE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DTA
In Commercial Distribution

  • 05060396173165 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

Axon 2 - 09413000095982

EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system

Persona Medical - 00851362008070

Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution

  • 00851362008070 ()


  • Air-conduction hearing aid, behind-the-ear

RXEars - 00851362008056

Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX8
In Commercial Distribution

  • 00851362008056 ()


  • Air-conduction hearing aid, behind-the-ear

RXEars - 00851362008018

Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX7
In Commercial Distribution

  • 00851362008018 ()


  • Air-conduction hearing aid, behind-the-ear

Frostmed PRO - 00860003258415

Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer

Frostmed LITE - 00860003258408

Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer

ARYS pro - 09120077180120

ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.
tyromotion GmbH
3
In Commercial Distribution

  • 09120077180120 ()


  • Biomechanical function analysis/rehabilitation software

GentleCath Hydrophilic Kit - 07333387044361

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 18FR
Wellspect AB
509019
In Commercial Distribution

  • 07333387044385 ()
  • 07333387044378 ()
  • 07333387044361 ()
  • 00768455142873 ()

  • Catheter Gauge: 18 French
  • Length: 16 Inch
509019

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044330

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 16FR
Wellspect AB
509018
In Commercial Distribution

  • 07333387044347 ()
  • 07333387044330 ()
  • 07333387044354 ()
  • 00768455142866 ()

  • Length: 16 Inch
  • Catheter Gauge: 16 French
509018

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044309

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 14FR
Wellspect AB
509017
In Commercial Distribution

  • 07333387044316 ()
  • 07333387044309 ()
  • 07333387044323 ()
  • 00768455142859 ()

  • Length: 16 Inch
  • Catheter Gauge: 14 French
509017

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044279

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 12FR
Wellspect AB
509016
In Commercial Distribution

  • 07333387044293 ()
  • 07333387044286 ()
  • 07333387044279 ()
  • 00768455142842 ()

  • Catheter Gauge: 12 French
  • Length: 16 Inch
509016

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044248

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 10FR
Wellspect AB
509015
In Commercial Distribution

  • 07333387044255 ()
  • 07333387044248 ()
  • 07333387044262 ()
  • 00768455142835 ()

  • Catheter Gauge: 10 French
  • Length: 16 Inch
509015

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044217

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 18FR
Wellspect AB
509014
In Commercial Distribution

  • 07333387044231 ()
  • 07333387044224 ()
  • 07333387044217 ()
  • 00768455142828 ()

  • Catheter Gauge: 18 French
  • Length: 16 Inch
509014

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044187

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 16FR
Wellspect AB
509013
In Commercial Distribution

  • 07333387044200 ()
  • 07333387044194 ()
  • 07333387044187 ()
  • 00768455142811 ()

  • Length: 16 Inch
  • Catheter Gauge: 16 French
509013

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044156

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 14FR
Wellspect AB
509012
In Commercial Distribution

  • 07333387044170 ()
  • 07333387044163 ()
  • 07333387044156 ()
  • 00768455142804 ()

  • Length: 16 Inch
  • Catheter Gauge: 14 French
509012

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044125

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 12FR
Wellspect AB
509011
In Commercial Distribution

  • 07333387044149 ()
  • 07333387044132 ()
  • 07333387044125 ()
  • 00768455142798 ()

  • Catheter Gauge: 12 French
  • Length: 16 Inch
509011

  • Single-administration urethral catheterization kit, single-use

GentleCath Hydrophilic Kit - 07333387044095

Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Male 16'' 10FR
Wellspect AB
509010
In Commercial Distribution

  • 07333387044101 ()
  • 07333387044095 ()
  • 07333387044118 ()
  • 00768455142781 ()

  • Length: 16 Inch
  • Catheter Gauge: 10 French
509010

  • Single-administration urethral catheterization kit, single-use
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