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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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Paragonix SherpaPak Cardiac Transport System - 00869582000330

Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
Paragonix Technologies Inc
SHRP-1001-003
Not in Commercial Distribution

  • 00869582000330 ()


  • General-purpose donor-organ preservation/transport system

Paragonix SherpaPak Cardiac Transport System - 00869582000316

Paragonix SherpaPak CTS Shipper Base
Paragonix Technologies Inc
SHRP-1001-001
In Commercial Distribution

  • 10869582000313 ()
  • 00869582000316 ()
  • 20869582000310 ()
  • 00850005470267 ()


  • General-purpose donor-organ preservation/transport system

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

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
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