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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™ - 00763000134556

PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
Not in Commercial Distribution

  • 20763000134550 ()
  • 00763000134556 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ - 00763000134532

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

  • 20763000134536 ()
  • 00763000134532 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors - 18051160302991

No Description
SPECTRUM MEDICAL SRL
CP22V-NG
In Commercial Distribution

  • 18051160302991 ()


  • Cardiopulmonary bypass system centrifugal pump

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

n/a - 00643169078284

GRIPPER EX0811554 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0811554
In Commercial Distribution

  • 00643169078284 ()


  • Surgical flat-nosed pliers

Medtronic Reusable Instruments - 00643169121669

ROD EX0112015 GRIPPER 5.5/6.0 VICE
MEDTRONIC SOFAMOR DANEK, INC.
EX0112015
In Commercial Distribution

  • 00643169121669 ()


  • Surgical flat-nosed pliers

Medtronic Reusable Instruments - 00643169106024

INTRODUCER EX1111572 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1111572
In Commercial Distribution

  • 00643169106024 ()


  • Surgical flat-nosed pliers

IN.PACT™ Admiral™ - 00643169859975

DEB ADM06012013P 06.00 L120 UL1300 US
MEDTRONIC, INC.
ADM06012013P
In Commercial Distribution

  • 00643169859975 ()

  • Balloon Diameter 6 MM
  • Balloon Length 120 MM


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169859968

DEB ADM06012008P 06.00 L120 UL800 US
MEDTRONIC, INC.
ADM06012008P
In Commercial Distribution

  • 00643169859968 ()

  • Balloon Length 120 MM
  • Balloon Diameter 6 MM


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576353

DEB ADM06015013P 06.00 L150 UL1300 US
MEDTRONIC, INC.
ADM06015013P
In Commercial Distribution

  • 00643169576353 ()

  • Length: 150.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576346

DEB ADM06015008P 06.00 L150 UL0800 US
MEDTRONIC, INC.
ADM06015008P
In Commercial Distribution

  • 00643169576346 ()

  • Balloon Length 150 MM
  • Balloon Diameter 6 MM


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576339

DEB ADM05015013P 05.00 L150 UL1300 US
MEDTRONIC, INC.
ADM05015013P
In Commercial Distribution

  • 00643169576339 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 150.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576322

DEB ADM05015008P 05.00 L150 UL0800 US
MEDTRONIC, INC.
ADM05015008P
In Commercial Distribution

  • 00643169576322 ()

  • Balloon Length 150 MM
  • Balloon Diameter 5 MM


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576315

DEB ADM04015013P 04.00 L150 UL1300 US
MEDTRONIC, INC.
ADM04015013P
In Commercial Distribution

  • 00643169576315 ()

  • Length: 150.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576308

DEB ADM04015008P 04.00 L150 UL0800 US
MEDTRONIC, INC.
ADM04015008P
In Commercial Distribution

  • 00643169576308 ()

  • Balloon Length 150 MM
  • Balloon Diameter 4 MM


  • Peripheral angioplasty balloon catheter, drug-coated
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