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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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30mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG053
In Commercial Distribution

  • 00850060751172 ()
  • 00850060751158 ()
  • 10850060751179 ()
  • 00850060751202 ()
PROGEN-A30

  • Autologous platelet-based product centrifuge tube
30mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG020
Not in Commercial Distribution

  • 00850060751165 ()
  • 00850060751141 ()
  • 10850060751162 ()


  • Autologous platelet-based product centrifuge tube
15mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG052
In Commercial Distribution

  • 00850060751134 ()
  • 00850060751110 ()
  • 10850060751131 ()
  • 00850060751196 ()
PROGEN-A15

  • Autologous platelet-based product centrifuge tube
15 mL Platelet Rich Plasma production device
Bellus Medical, LLC
P5PG019
Not in Commercial Distribution

  • 00850060751127 ()
  • 00850060751103 ()
  • 10850060751124 ()


  • Autologous platelet-based product centrifuge tube
SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile docking compatible tubing to vacuum containers for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory
ITL ASIA PACIFIC SDN. BHD.
A100756
In Commercial Distribution

  • 19555240405613 ()
  • 09555240405616 ()
A100756

  • Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100752
Not in Commercial Distribution

  • 19555240403862 ()
  • 09555240403865 ()
A100752

  • Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk3-10mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100750
In Commercial Distribution

  • 19555240400731 ()
  • 09555240400734 ()
A100750

  • Blood/blood culture specimen transfer spike IVD, manual
SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests.
ITL ASIA PACIFIC SDN. BHD.
A100740
In Commercial Distribution

  • 19555240400533 ()
  • 09555240400536 ()
A100740

  • Blood/blood culture specimen transfer spike IVD, manual
Thawing and warming device for HPC, blood products, IV solution
Barkey GmbH & Co. KG
US-C&G 2.Gen
In Commercial Distribution

  • 04059201002135 ()
00010340

  • Cryopreserved blood/tissue thawing unit
Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-C&G
In Commercial Distribution

  • 04059201001817 ()
00003475

  • Cryopreserved blood/tissue thawing unit
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