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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 - 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

Voca - 00781096541980

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Slate Black/Grey
In Commercial Distribution

  • 00781096541980 ()
VCKONGSBGY00PRO

  • Spectacle frame

Voca - 00781096541973

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Midnight Frost/Green
In Commercial Distribution

  • 00781096541973 ()
VCKONGMFGN00PRO

  • Spectacle frame

Voca - 00781096541966

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Arctic White/Grey
In Commercial Distribution

  • 00781096541966 ()
VCKONGAWGY00PRO

  • Spectacle frame

Voca - 00781096541669

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Slate Black/Grey
In Commercial Distribution

  • 00781096541669 ()
VCKONGSBGY00SND

  • Spectacle frame

Voca - 00781096541652

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Midnight Frost Green
In Commercial Distribution

  • 00781096541652 ()
VCKONGMFGN00SND

  • Spectacle frame

Voca - 00781096541645

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Arctic White/Grey
In Commercial Distribution

  • 00781096541645 ()
VCKONGAWGY00SND

  • Spectacle frame

Voca - 00781096541638

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Arctic White/Blue
In Commercial Distribution

  • 00781096541638 ()
VCKONGAWBL00SND

  • Spectacle frame

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
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