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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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The Völkner® Turning System - 00853360007062

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

  • 00853360007062 ()


  • Low-air-loss bed
  • Alternating-pressure inflator

The Völkner® Turning System - 00853360007048

No Description
JAMES CONSOLIDATED, INC.
EUROPA I Mattress Overlay
In Commercial Distribution

  • 00853360007048 ()


  • Alternating-pressure inflator
  • Low-air-loss bed

The Völkner® Turning System - 00853360007031

No Description
JAMES CONSOLIDATED, INC.
MARK II Mattress Replacement
In Commercial Distribution

  • 00853360007031 ()


  • Alternating-pressure inflator
  • Low-air-loss bed

The Völkner® Turning System - 00853360007024

No Description
JAMES CONSOLIDATED, INC.
MARK I Mattress Overlay
In Commercial Distribution

  • 00853360007024 ()


  • Low-air-loss bed
  • Alternating-pressure inflator

The Völkner® Turning System - 00853360007017

No Description
JAMES CONSOLIDATED, INC.
BETA II Mattress Replacement
In Commercial Distribution

  • 00853360007017 ()


  • Low-air-loss bed
  • Alternating-pressure inflator

The Völkner® Turning System - 00853360007000

No Description
JAMES CONSOLIDATED, INC.
BETA I Mattress Overlay
In Commercial Distribution

  • 00853360007000 ()


  • Alternating-pressure inflator
  • Low-air-loss bed

Bio30+ Sys Physio HP EZ Nin - 05056336800239

Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab software
BIOCHROM LIMITED
80-6000-53EZ
In Commercial Distribution

  • 05056336800239 ()


  • Amino acid analyser IVD

Waste Transfer Set - 04052682031724

For Red Blood Cell Exchange (RBCX) Procedures. For use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2172
In Commercial Distribution

  • 04052682031724 ()
  • 14052682031721 ()
X6C2172

  • Blood transfer set

PROTEK Duo - 00814112020173

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

ProtekDuo - 00814112020418

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
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