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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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Affinity™ - 00763000134532

PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20763000134536 ()
  • 00763000134532 ()


  • Cardiopulmonary bypass system centrifugal pump

DABRA 101 Catheter - 00842362100031

Percutaneous Catheter
Catheter Precision, Inc.
101
In Commercial Distribution

  • 00842362100031 ()


  • Atherectomy laser system beam guide-catheter, peripheral

A1c-Cellular - 00844509000945

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.
STRECK, INC.
211130
In Commercial Distribution

  • 00844509000945 ()

  • Total Volume: 2.0 Milliliter
211130

  • Glycated haemoglobin (HbA1c) IVD, control

A1c-Cellular - 00844509000938

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2.
STRECK, INC.
211124
In Commercial Distribution

  • 00844509000938 ()

  • Total Volume: 2.0 Milliliter
211124

  • Glycated haemoglobin (HbA1c) IVD, control

Pointe Scientific, Inc. - 00811727011336

Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml
POINTE SCIENTIFIC, INC.
G7540-2
In Commercial Distribution

  • 00811727011336 ()
G7540-2

  • Glycated haemoglobin (HbA1c) IVD, control

LifeSPARC - 00814112020807

LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Rapid Depolyment Cannula
CARDIACASSIST, INC.
5820-3631
Not in Commercial Distribution

  • 00814112020807 ()


  • Vascular dilator, single-use
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Mobile extracorporeal gas exchange system catheter kit

LifeSPARC - 00814112020791

LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Cannula
CARDIACASSIST, INC.
5820-3118
Not in Commercial Distribution

  • 00814112020791 ()


  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump

LifeSPARC - 00814112020784

LifeSPARC Blood Pump Kit with 29 Fr ProtekDuo Veno-Venous Cannula
CARDIACASSIST, INC.
5820-2916
Not in Commercial Distribution

  • 00814112020784 ()


  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump

Suction Valve Holder - 04953170438219

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MD-51
Not in Commercial Distribution

  • 04953170438219 ()
N6178001

  • Endoscope working-channel valve, reusable

Biopsy Valve - 04953170438202

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MD-495
In Commercial Distribution

  • 84953170064117 ()
  • 04953170438202 ()
N6177901

  • Endoscope working-channel valve, reusable
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