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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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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
E-Scribe ECG Data Management Workstation - Enterprise system, node- locked; English system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323146 ()
ESWKST-CAX-BXXXX

  • Patient health record information system application software
E-Scribe ECG Data Management Workstation - Enterprise system, node- locked; Italian system language; Software Only
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094323139 ()
ESWKST-CEX-BXXXX

  • Patient health record information system application software
Piezo Crystal Sensor & Band (adult/ped) Double Buckle (Sleepmate item 1310) Min. purchase is 5 pcs. = 1 set
Ambu A/S
813236-100
In Commercial Distribution

  • 05707480041343 ()
813236-100

  • Polysomnograph
Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.
SENSEONICS, INCORPORATED
FG-4002-01-001
In Commercial Distribution

  • 00817491024251 ()
FG-4002-01-001

  • Implantable glucose monitoring system transmitter
Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.
SENSEONICS, INCORPORATED
FG-5902-01-001
In Commercial Distribution

  • 00817491022936 ()
FG-5902-01-001

  • Implantable glucose monitoring system transmitter
Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.
SENSEONICS, INCORPORATED
FG-3302-01-001
Not in Commercial Distribution

  • 00817491022516 ()
FG-3302-01-001

  • Implantable glucose monitoring system transmitter
BEIGE/990013-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990013-SWH
In Commercial Distribution

  • 00850016231130 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990005-SWH; left replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990005-SWH
In Commercial Distribution

  • 00850016231055 ()


  • Air-conduction hearing aid, receiver-in-canal
GREY/990004-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990004-SWH
In Commercial Distribution

  • 00850016231048 ()


  • Air-conduction hearing aid, receiver-in-canal
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