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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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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

Source Exchange Tube for Container T41, Ir-192 - 04049223106058

No Description
Eckert & Ziegler BEBIG GmbH
LAZ20-04
Not in Commercial Distribution

  • 04049223106058 ()
LAZ20-04

  • Brachytherapy system remote afterloading source safe

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

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937647

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8218
In Commercial Distribution

  • 04710961937647 ()
  • 14710961937644 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937630

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8216
In Commercial Distribution

  • 04710961937630 ()
  • 14710961937637 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937623

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8214
In Commercial Distribution

  • 04710961937623 ()
  • 14710961937620 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Integrated Balloon) - 04710961937616

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
4890-8212
In Commercial Distribution

  • 04710961937616 ()
  • 14710961937613 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934257

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8224
In Commercial Distribution

  • 04710961934257 ()
  • 14710961934254 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934240

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8222
In Commercial Distribution

  • 04710961934240 ()
  • 14710961934247 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934233

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8220
In Commercial Distribution

  • 04710961934233 ()
  • 14710961934230 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934226

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8218
In Commercial Distribution

  • 04710961934226 ()
  • 14710961934223 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934219

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8216
In Commercial Distribution

  • 04710961934219 ()
  • 14710961934216 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934202

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8214
In Commercial Distribution

  • 04710961934202 ()
  • 14710961934209 ()


  • Suprapubic drainage catheter

Silicone Supra-Pubic Catheter Exchange Set (Ordinary Balloon) - 04710961934196

No Description
FORTUNE MEDICAL INSTRUMENT CORP.
1890-8212
In Commercial Distribution

  • 04710961934196 ()
  • 14710961934193 ()


  • Suprapubic drainage catheter
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