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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Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter
DATASCOPE CORP.
BO-T 25102
Not in Commercial Distribution

  • 00607567203327 ()
701052463

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 800ml, Gish Bladder Bag 30ml 1/4, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BO-T 13303
Not in Commercial Distribution

  • 00607567202665 ()
701052539

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 2917
Not in Commercial Distribution

  • 00607567202092 ()
701053384

  • Cardiopulmonary bypass system blood tubing set
BO-RF32 RotaFlow
DATASCOPE CORP.
BO-T 22800
Not in Commercial Distribution

  • 00607567201774 ()
701051272

  • Cardiopulmonary bypass system blood tubing set
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
A digital epilepsy care management platform application for iOS.
Ai Nile Inc
Nile for iOS
In Commercial Distribution

  • 00850031821002 ()


  • Medication reminder application software
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Tandem Diabetes Care, Inc.
1007111
In Commercial Distribution

  • 90850018992452 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control
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