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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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Elecsys HIV combi PT - 04015630942497

HIV combi PT Elecsys cobas e 100
Roche Diagnostics GmbH
05390095160
In Commercial Distribution

  • 04015630942497 ()
05390095160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Eurotrol - 08718734960409

Assayed Quality control solution
Eurotrol B.V.
188.003.002
In Commercial Distribution

  • 08718734960409 ()
  • 08718734960416 ()
188.003.002

  • Total haemoglobin (totHb) IVD, control

Eurotrol - 08718734960386

Assayed Quality control solution
Eurotrol B.V.
188.002.002
In Commercial Distribution

  • 08718734960386 ()
  • 08718734960393 ()
188.002.002

  • Total haemoglobin (totHb) IVD, control

Eurotrol - 08718734960362

Assayed Quality control solution
Eurotrol B.V.
188.001.002
In Commercial Distribution

  • 08718734960362 ()
  • 08718734960379 ()
188.001.002

  • Total haemoglobin (totHb) IVD, control

SGP (Plasma Management System) - 00817955020010

SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
BIOMAT USA, INC.
7
In Commercial Distribution

  • 00817955020010 ()


  • Blood bank information system application software

Maximus Processing System Blood PRP Kit - B73810071

To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Holding Technologies, LLC
1007
Not in Commercial Distribution

  • B73810071 ()


  • Haematological concentrate system

CryoStore - 10816203023152

CryoStore 500 EVA Freezing Bag, 8-bag set, 55-100ml, "V8" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500V8
Not in Commercial Distribution

  • 20816203023159 ()
  • 10816203023152 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203022865

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750N
In Commercial Distribution

  • 10816203022865 ()
  • 00816203022868 ()
  • 20816203022862 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203022247

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1A
Not in Commercial Distribution

  • 20816203022244 ()
  • 10816203022247 ()
  • 00816203022240 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021226

Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
Not in Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020731

Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000NS
Not in Commercial Distribution

  • 10816203020731 ()
  • 20816203020738 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020724

CryoStore 1000 EVA Freezing Bag, 120 - 275 ml, "N" Tubing Set
ORIGEN BIOMEDICAL, INC.
CS1000N
In Commercial Distribution

  • 20816203020721 ()
  • 10816203020724 ()
  • 00816203020727 ()
CS1000N

  • Blood/tissue storage/culture container

CryoStore - 10816203020717

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F21" Tubing Set, with IBS and male luer cap, singly packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS250F21P
Not in Commercial Distribution

  • 20816203020714 ()
  • 10816203020717 ()


  • Blood/tissue storage/culture container

Cryostore Harvest Kit - 10816203020526

Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS750Y12S
Not in Commercial Distribution

  • 10816203020526 ()
  • 20816203020523 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020519

Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, double aseptically pouched, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3S
Not in Commercial Distribution

  • 10816203020519 ()
  • 20816203020516 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020502

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 12, singly packed in triple O-Wrap
ORIGEN BIOMEDICAL, INC.
CS750NSWT
Not in Commercial Distribution

  • 10816203020502 ()
  • 20816203020509 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020434

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, double aseptic packed with OW
ORIGEN BIOMEDICAL, INC.
CS50NSW
Not in Commercial Distribution

  • 10816203020434 ()
  • 20816203020431 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020427

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS50NS
In Commercial Distribution

  • 10816203020427 ()
  • 20816203020424 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020410

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50N
In Commercial Distribution

  • 20816203020417 ()
  • 10816203020410 ()
  • 00816203020413 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020403

Cryostore 500 EVA 3-Bag set with spike, 55-100ml, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS500V3S
Not in Commercial Distribution

  • 10816203020403 ()
  • 20816203020400 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020397

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 12, singly packed in triple OW
ORIGEN BIOMEDICAL, INC.
CS500NSWT
Not in Commercial Distribution

  • 10816203020397 ()
  • 20816203020394 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020380

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" tube set, case of 12, double aseptic packed in OW
ORIGEN BIOMEDICAL, INC.
CS500NSW
In Commercial Distribution

  • 10816203020380 ()
  • 20816203020387 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020373

CryoStore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS500NS
In Commercial Distribution

  • 10816203020373 ()
  • 20816203020370 ()
CS500NS

  • Blood/tissue storage/culture container

Cryostore - 10816203020366

CryoStore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500N
In Commercial Distribution

  • 20816203020363 ()
  • 10816203020366 ()
  • 00816203020369 ()
CS500N

  • Blood/tissue storage/culture container

Cryostore - 10816203020359

CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution

  • 20816203020356 ()
  • 10816203020359 ()
  • 00816203020352 ()
CS25N

  • Blood/tissue storage/culture container

Cryostore - 10816203020342

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS250Y12S
Not in Commercial Distribution

  • 10816203020342 ()
  • 20816203020349 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020335

CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set, double aseptically packed in OW
ORIGEN BIOMEDICAL, INC.
CS250NSW
In Commercial Distribution

  • 10816203020335 ()
  • 20816203020332 ()
CS250NSW

  • Blood/tissue storage/culture container

Cryostore - 10816203020328

CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250NS
In Commercial Distribution

  • 10816203020328 ()
  • 20816203020325 ()
CS250NS

  • Blood/tissue storage/culture container

Cryostore - 10816203020304

Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000aY8SW
Not in Commercial Distribution

  • 10816203020304 ()
  • 20816203020301 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020298

Cryostore 1950 EVA Freezing Bag, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1950aY8SW
Not in Commercial Distribution

  • 10816203020298 ()
  • 20816203020295 ()


  • Blood/tissue storage/culture container
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