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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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Dream Sock App - 00810099090819

Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution

  • 00810099090819 ()


  • Multiple vital physiological parameter monitoring system, home-use

Lifeline Response App - 00884838082137

SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution

  • 00884838082137 ()
mSafe

  • Vulnerable patient home alert system

Lifeline Response App - 00884838082120

SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution

  • 00884838082120 ()
mSafe

  • Vulnerable patient home alert system

N/A - 00721902865572

SFTWR 9730896 CRANIAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730896
In Commercial Distribution

  • 00721902865572 ()


  • Multi-purpose stereotactic surgery system

WIDEX - 05706069779714

APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control

WIDEX - 05706069779707

APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control

Cell Therapy 360 Wearable Tech V1 - 00851203006272

BMS CT360 Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Clinician Web App
Not in Commercial Distribution

  • 00851203006272 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006265

BMS CT360 Andriod Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Andriod Clinician App
Not in Commercial Distribution

  • 00851203006265 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006258

BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006241

BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Cell Therapy 360 Wearable Tech V1 - 00851203006234

BMS CT360 Android Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 Android Patient App
Not in Commercial Distribution

  • 00851203006234 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Widex - 05706069674729

Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software

Widex - 05706069674712

Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software

Widex - 05706069673579

BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673579 ()
5 300 0005 001

  • Hearing aid/implant system remote control

Widex - 05706069673562

BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673562 ()
5 300 0004 001

  • Hearing aid/implant system remote control

hearX - 00858177007465

Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007465 ()
Lexie Android App

  • Audiometric/hearing device software

hearX - 00858177007458

IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software

GN Hearing - 05708296074259

APP,GNH TUNER,3.4,ANDR
Gn Hearing A/S
20417000
In Commercial Distribution

  • 05708296074259 ()


  • Hearing aid/implant system remote control

GN Hearing - 05708296074242

APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution

  • 05708296074242 ()


  • Hearing aid/implant system remote control

Beltone - 05708296074235

APP,BT HEARP,3.4,ANDR
Gn Hearing A/S
20416800
In Commercial Distribution

  • 05708296074235 ()


  • Hearing aid/implant system remote control
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