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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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CELSIOR Cold Storage Solution - 13700911900126

Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.
INSTITUT GEORGES LOPEZ
CELSIOR 1L US
In Commercial Distribution

  • 13700911900126 ()
  • 23700911900123 ()
533682

  • Donor-organ/tissue/cell preservation solution

Servator H - 00851983008060

Servator H Solution is intended for flushing and cold storage of abdominal organs at the time of removal from the donor in preparation fort storage, transportation, and the eventual transplantation into a recipient.
GLOBAL TRANSPLANT SOLUTIONS, INC.
GTS-SERV-HTK-5000
In Commercial Distribution

  • 00851983008060 ()


  • Kidney donor-organ preservation/transport perfusion set

Paragonix SherpaPak Cardiac Transport System - 10850005470271

SherapaPak SherpaCool Ribbons and Pouch
Paragonix Technologies Inc
SHRP-1001-002
In Commercial Distribution

  • 10850005470271 ()
  • 20850005470278 ()


  • General-purpose donor-organ preservation/transport system

OCS Lung Donor Flush Set - B00958753

OCS Lung Donor Flush Set
TRANSMEDICS, INC.
2406
In Commercial Distribution

  • B00958755 ()
  • B00958753 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2406

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

XprESS Pro - 00857326005079

ENT Dilation System 6x8mm
STRYKER CORPORATION
MSB
Not in Commercial Distribution

  • 00857326005079 ()
JD-206

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use

XprESS Pro - 00857326005062

ENT Dilation System 7x18mm
STRYKER CORPORATION
MSB
Not in Commercial Distribution

  • 00857326005062 ()
JD-107

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use

XprESS Pro - 00857326005055

ENT Dilation System 6x18mm
STRYKER CORPORATION
MSB
Not in Commercial Distribution

  • 00857326005055 ()
  • 10857326005052 ()
JD-106

  • Nasal/paranasal balloon catheter
  • Eustachian catheter, single-use

SNT Biotech - 06973471960729

3 ml of 0.85% Sterile Normal Saline in screw-cap tube, with nasopharyngeal swab.
Shenzhen Dakewe Bio-engineering Co., Ltd
MSB
In Commercial Distribution

  • 06973471960729 ()


  • General tissue specimen container IVD, fixative/saline

Biosci™ - 06973471960705

3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with nasopharyngeal swab.
Shenzhen Dakewe Bio-engineering Co., Ltd
MSB
In Commercial Distribution

  • 06973471960705 ()


  • General tissue specimen container IVD, fixative/saline

OCS Lung System - B00944670

OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution

  • B00944671 ()
  • B00944670 ()

  • Height: 2.5 Inch
  • Width: 5.5 Inch
  • Length: 14 Inch
2300

  • Donor-organ/tissue/cell preservation solution
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