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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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Bile Cannula, 12FR
TRANSMEDICS, INC.
3450
In Commercial Distribution

  • B00950443 ()
  • B00950421 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3450

  • Donor-organ preservation/transport perfusion set connection kit
OCS Heart Solution Line Set
TRANSMEDICS, INC.
1457
In Commercial Distribution

  • B00948913 ()
  • B00948925 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1457

  • Donor-organ preservation/transport perfusion initiation/termination set
OCS Heart Perfusion Set
TRANSMEDICS, INC.
1200
In Commercial Distribution

  • B00948225 ()
  • B00948227 ()

  • Length: 31 Inch
  • Width: 18 Inch
  • Height: 18 Inch
1200

  • Heart donor-organ preservation/transport perfusion set
Cable Tie Tool, Small Diameter
TRANSMEDICS, INC.
1461
In Commercial Distribution

  • B00943661 ()
  • B00943675 ()

  • Length: 12 Inch
  • Width: 9 Inch
  • Height: 2 Inch
1461

  • Donor-organ preservation/transport perfusion set vessel tie tool
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
No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system
Sterile IV Administration Set 15Dr/ml 100" With Injection Site.
American Health Service Sales Corporation
IV15
In Commercial Distribution

  • B031IV151 ()
  • B031IV150 ()


  • Basic intravenous administration set, noninvasive
Gown,Surgeon,Sterile,W/Towel,XXXXX-Large
American Health Service Sales Corporation
AHSSGXXXXXL
In Commercial Distribution

  • B031AHSSGXXXXXL1 ()
  • B031AHSSGXXXXXL0 ()


  • Surgical gown, single-use
Gown,Surgeon,Sterile,W/Towel,XXX-Large
American Health Service Sales Corporation
AHSSGXXXL
In Commercial Distribution

  • B031AHSSGXXXL1 ()
  • B031AHSSGXXXL0 ()


  • Surgical gown, single-use
A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
NOVOSCI CORP.
491196-A
In Commercial Distribution

  • B066491196A3 ()
  • B066491196A0 ()
491196-A

  • Cardiopulmonary bypass system blood tubing set
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