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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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No Description
JAMES CONSOLIDATED, INC.
PANDA III 48" Bariatric Mattress Replacement
In Commercial Distribution

  • 00853360007062 ()


  • Low-air-loss bed
  • Alternating-pressure inflator
No Description
JAMES CONSOLIDATED, INC.
EUROPA I Mattress Overlay
In Commercial Distribution

  • 00853360007048 ()


  • Alternating-pressure inflator
  • Low-air-loss bed
No Description
JAMES CONSOLIDATED, INC.
MARK II Mattress Replacement
In Commercial Distribution

  • 00853360007031 ()


  • Alternating-pressure inflator
  • Low-air-loss bed
No Description
JAMES CONSOLIDATED, INC.
MARK I Mattress Overlay
In Commercial Distribution

  • 00853360007024 ()


  • Low-air-loss bed
  • Alternating-pressure inflator
No Description
JAMES CONSOLIDATED, INC.
BETA II Mattress Replacement
In Commercial Distribution

  • 00853360007017 ()


  • Low-air-loss bed
  • Alternating-pressure inflator
No Description
JAMES CONSOLIDATED, INC.
BETA I Mattress Overlay
In Commercial Distribution

  • 00853360007000 ()


  • Alternating-pressure inflator
  • Low-air-loss bed
TandemHeart blood pump kit with veno-venous cannula
CARDIACASSIST, INC.
5190-0020
Not in Commercial Distribution

  • 00814112020173 ()


  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Mobile extracorporeal gas exchange system catheter kit
TandemHeart blood pump kit with 31 Fr veno-venous cannula
CARDIACASSIST, INC.
5720-3118
Not in Commercial Distribution

  • 00814112020418 ()


  • Cardiopulmonary bypass system mounting unit
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump
TandemHeart blood pump kit with 29 Fr veno-venous cannula
CARDIACASSIST, INC.
5720-2916
Not in Commercial Distribution

  • 00814112020401 ()


  • Cardiopulmonary bypass system mounting unit
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system centrifugal pump
Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Slate Black/Grey
In Commercial Distribution

  • 00781096541980 ()
VCKONGSBGY00PRO

  • Spectacle frame
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