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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No Description
DATASCOPE CORP.
BO-T 52303
In Commercial Distribution

  • 00607567211544 ()
709000408

  • Cardiopulmonary bypass system blood tubing set
Softshell Venous Reser. 1900ml w. connector 700000292, BO-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BO-T 39705
In Commercial Distribution

  • 00607567211490 ()
709000415

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 14608
Not in Commercial Distribution

  • 00607567211476 ()
709000224

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 14607
Not in Commercial Distribution

  • 00607567211469 ()
709000222

  • Cardiopulmonary bypass system blood tubing set
No Description
DATASCOPE CORP.
BO-T 14606
Not in Commercial Distribution

  • 00607567211452 ()
709000220

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

  • 00386270001931 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
Vial Adapter 20mm ML TG SS Blue SIL- VF
WEST PHARMA. SERVICES IL, . LTD
8072028
Not in Commercial Distribution

  • 27290108240003 ()
  • 17290108240006 ()
  • 07290108240009 ()


  • Vial/bottle adaptor, non-hermetic
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