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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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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

HUDSON RCI - 04026704588626

ET TUBE, EXCHANGER, ETX, 35 - 41 FR
TELEFLEX INCORPORATED
IPN044923
In Commercial Distribution

  • 24026704588620 ()
  • 04026704588626 ()
  • 44026704588624 ()

  • Length: 1000 Millimeter
  • Sheridan E.T.X. Endobronchial Tube Exchanger
5-24105

  • Endotracheal tube guide, single-use

Affinity™ CP - 00763000301323

ADAPTER AP40AST AFFINITY CP WW 31L
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00763000301323 ()

  • Outer Diameter: 94.0 Millimeter
  • Height: 28.0 Millimeter
  • Weight: 315.0 Gram


  • Cardiopulmonary bypass system centrifugal pump

InQwire® - 00884450021637

No Description
Merit Medical Systems, Inc.
00884450021637
In Commercial Distribution

  • 10884450021634 ()
  • 00884450021637 ()

  • Configuration-Standard J 3.0 mm Tip Exchange
  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Tip Shape-3 mm J-Tip; Configuration-Standard J 3.0 mm Tip Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102")
  • Length-260 cm (102"); Configuration-Standard J 3.0 mm Tip Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102")
IQR35F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use

Disposable tubings with luer lock for air-fluid exchange - 08717872000619

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1250.B
Not in Commercial Distribution

  • 08717872000619 ()
  • 18717872000616 ()
1250.B

  • Surgical irrigation/aspiration tubing set

Disposable tubings complete with filter for air-fluid exchange - 08717872000602

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1250.ABD
In Commercial Distribution

  • 08717872000602 ()
  • 18717872000609 ()
1250.ABD

  • Surgical irrigation/aspiration tubing set

Disposable EVA Double Irrigation Line with Air Exchange - 08717872020952

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8110.DIL01
In Commercial Distribution

  • 08717872020952 ()
  • 18717872020959 ()
8110.DIL01

  • Surgical irrigation/aspiration tubing set

ICY® Intravascular Heat Exchange Catheter Kit (Heparin) - 00849111075107

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-3893AE
In Commercial Distribution

  • 00849111075107 ()

  • Length: 38 Centimeter
  • Catheter Gauge: 9.3 French
8700-0657-40

  • Intravascular core temperature regulation system catheter

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 - 00841036041618

No Description
BIOMET MICROFIXATION, INC
28-1010
In Commercial Distribution

  • 00841036041618 ()
28-1010

  • Surgical flat-nosed pliers

N/A - 00841036027650

No Description
BIOMET MICROFIXATION, INC
09-0193
In Commercial Distribution

  • 00841036027650 ()
09-0193

  • Surgical flat-nosed pliers

N/A - 00841036027643

No Description
BIOMET MICROFIXATION, INC
09-0192
In Commercial Distribution

  • 00841036027643 ()
09-0192

  • Surgical flat-nosed pliers

N/A - 00841036027612

No Description
BIOMET MICROFIXATION, INC
09-0184
In Commercial Distribution

  • 00841036027612 ()
09-0184

  • Surgical flat-nosed pliers

N/A - 00841036023591

No Description
BIOMET MICROFIXATION, INC
03-0072
In Commercial Distribution

  • 00841036023591 ()
03-0072

  • Surgical flat-nosed pliers

N/A - 00841036022211

No Description
BIOMET MICROFIXATION, INC
02-5593
In Commercial Distribution

  • 00841036022211 ()
02-5593

  • Surgical flat-nosed pliers

N/A - 00841036022198

No Description
BIOMET MICROFIXATION, INC
02-5588
In Commercial Distribution

  • 00841036022198 ()
02-5588

  • Surgical flat-nosed pliers

AESCULAP - 04038653149230

PLANERT Crown Dilating Forceps, 5 1/2", (140 mm), non-sterile, reusable
Aesculap AG
DP788R
In Commercial Distribution

  • 04038653149230 ()
DP788R

  • Surgical flat-nosed pliers

AESCULAP - 04038653050390

WOLFF Plaster Removal Forceps, 9 1/2", (240 mm), non-sterile, reusable
Aesculap AG
LX624R
In Commercial Distribution

  • 04038653050390 ()
LX624R

  • Surgical flat-nosed pliers
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