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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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Abiomed Breethe OXY-1 System - 00813502013184

TUBING INSULATOR KIT
Breethe, Inc.
2000735
In Commercial Distribution

  • 00813502013184 ()
2000735

  • Cardiopulmonary bypass system, non-roller type

MCV Infant ECC Pack with QPiD - 00607567205482

701050970 BEQ-HMOD 30000-USA Pediatric Quadrox iD 701066544 BO-VHK 310000 Venous res Pediatric 701054444 Better Bladder 701020489 BEQ-RF32 RotaFLow 701045763 Gas Filter
DATASCOPE CORP.
BEQ-TOP 28901
Not in Commercial Distribution

  • 00607567205482 ()
701056771

  • Cardiopulmonary bypass system, non-roller type

OCS Lung System - B00943281

OCS Lung Perfusion Initiation Set
TRANSMEDICS, INC.
2402
In Commercial Distribution

  • B00943281 ()
  • B00937703 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2402

  • Donor-organ preservation/transport perfusion initiation/termination set

OCS Lung System - B00940001

OCS Lung Manual Inflation Set
TRANSMEDICS, INC.
2404
In Commercial Distribution

  • B00940013 ()
  • B00940001 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2404

  • Breathing circuit bag, single-use

OCS Lung System - B00939111

OCS Lung Instrumentation Tool Set
TRANSMEDICS, INC.
2401
In Commercial Distribution

  • B00937673 ()
  • B00939111 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2401

  • Donor-organ preservation/transport perfusion set connection kit

OCS Lung System - B00938535

OCS Lung Perfusion Set
TRANSMEDICS, INC.
2200
In Commercial Distribution

  • B00938535 ()
  • B00938537 ()

  • Height: 21 Inch
  • Width: 27 Inch
  • Length: 27 Inch
2200

  • Lung donor-organ preservation/transport perfusion set

OCS Lung System - B00937641

OCS Lung Perfusion Termination Set
TRANSMEDICS, INC.
2403
In Commercial Distribution

  • B00937663 ()
  • B00937641 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2403

  • Donor-organ preservation/transport perfusion initiation/termination set

Extend Frame system - 07340048305372

SALIVA STOP 1 PCS
Elekta Instrument AB
1526875
Not in Commercial Distribution

  • 07340048305372 ()


  • Teletherapy radionuclide system, conventional

Extend Frame system - 07340048305341

SALIVA STOP PCU (1 PCS)
Elekta Instrument AB
1526861
Not in Commercial Distribution

  • 07340048305341 ()


  • Teletherapy radionuclide system, conventional

QUICKIE PRIME - 32" W/2 SPIKES - B0663011320000

A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301132-000
In Commercial Distribution

  • B0663011320006 ()
  • B0663011320000 ()
301132-000

  • Cardiopulmonary bypass system priming set
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