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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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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

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

ProtekDuo - 00814112020401

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

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

Medline - 10888277699526

SZ 4, DISP, SOFT, MASK, LARYNGEAL, PVC
MEDLINE INDUSTRIES, INC.
DYND300040S
In Commercial Distribution

  • 20888277699523 ()
  • 10888277699526 ()
DYND300040S

  • Laryngeal mask airway, single-use
  • Oropharyngeal airway, single-use

Medline - 20888277367996

50MM,BLUE,SOFT GUEDEL AIRWAY
MEDLINE INDUSTRIES, INC.
DYNJGUED50
In Commercial Distribution

  • 10888277367999 ()
  • 20888277367996 ()
DYNJGUED50

  • Oropharyngeal airway, single-use
  • Laryngeal mask airway, single-use

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937678

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8224
In Commercial Distribution

  • 04710961937678 ()
  • 14710961937675 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937661

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8222
In Commercial Distribution

  • 04710961937661 ()
  • 14710961937668 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937654

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8220
In Commercial Distribution

  • 04710961937654 ()
  • 14710961937651 ()


  • Suprapubic drainage catheter
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