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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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Cryostore - 10816203020878

Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F4
Not in Commercial Distribution

  • 20816203020875 ()
  • 10816203020878 ()
  • 00816203020871 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020854

CryoStore multiple bag set, 10 x CS50 EVA freezing bags + 1 x CS750 EVA freezing bag, sterile
ORIGEN BIOMEDICAL, INC.
CS50V7
In Commercial Distribution

  • 10816203020854 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020847

Cryostore 250 EVA Freezing Bag, 250ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1
Not in Commercial Distribution

  • 20816203020844 ()
  • 10816203020847 ()
  • 00816203020840 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020830

Cryostore 250 EVA Freezing Bag, 30-70ml, "F" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F
Not in Commercial Distribution

  • 20816203020837 ()
  • 10816203020830 ()
  • 00816203020833 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020823

CryoStore 250 EVA Freezing Bag, 30-70ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250
In Commercial Distribution

  • 20816203020820 ()
  • 10816203020823 ()
  • 00816203020826 ()
CS250

  • Blood/tissue storage/culture container

Cryostore - 10816203020816

Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y5" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000Y5
Not in Commercial Distribution

  • 10816203020816 ()
  • 20816203020813 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020809

CryoStore 2000 EVA Freezing Bag, 180-450ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS2000NS
In Commercial Distribution

  • 10816203020809 ()
  • 20816203020806 ()
CS2000NS

  • Blood/tissue storage/culture container

Cryostore - 10816203020793

Cryostore 2000 EVA Freezing Bag, 180-450 ml, "N" Tubing Set, singly pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000NP
Not in Commercial Distribution

  • 10816203020793 ()
  • 20816203020790 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020786

CryoStore 2000 EVA Freezing Bag, 180 - 450 ml, "N" tube set
ORIGEN BIOMEDICAL, INC.
CS2000N
In Commercial Distribution

  • 20816203020783 ()
  • 10816203020786 ()
  • 00816203020789 ()
CS2000N

  • Blood/tissue storage/culture container

Cryostore - 10816203020779

Cryostore 1000 EVA Freezing Bag, "Y4" Tubing Set, one bag per pouch, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000Y4S
Not in Commercial Distribution

  • 10816203020779 ()
  • 20816203020776 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020762

CryoStore 1000 EVA Freezing Bag, 3-bag Set, 120 - 275 ml, "V4" Tube Set, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS1000V4
Not in Commercial Distribution

  • 10816203020762 ()
  • 20816203020769 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020755

CryoStore 1000 EVA Freezing Bag, 3-bag Set, 120 - 275 ml, "V3" Tube Set, case of 12 sets
ORIGEN BIOMEDICAL, INC.
CS1000V3
Not in Commercial Distribution

  • 10816203020755 ()
  • 20816203020752 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020748

Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000NSW
Not in Commercial Distribution

  • 10816203020748 ()
  • 20816203020745 ()


  • 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 - 10816203020496

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" tube set, case of 12, double aseptic packed in O-Wrap
ORIGEN BIOMEDICAL, INC.
CS750NSW
In Commercial Distribution

  • 10816203020496 ()
  • 20816203020493 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020489

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS750NS
In Commercial Distribution

  • 10816203020489 ()
  • 20816203020486 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020465

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double aseptic packed in O-Wrap
ORIGEN BIOMEDICAL, INC.
CS750M2SW
Not in Commercial Distribution

  • 10816203020465 ()
  • 20816203020462 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020458

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750M2
Not in Commercial Distribution

  • 20816203020455 ()
  • 10816203020458 ()
  • 00816203020451 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203020441

Cryostore 50 EVA 4-Bag Set, 10-30ml, "Standard" Tubing Set, double aseptically pouched with OW, case of 6
ORIGEN BIOMEDICAL, INC.
CS50V4SW
Not in Commercial Distribution

  • 10816203020441 ()
  • 20816203020448 ()


  • 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

Hematype Segment Device - 10810020440536

Hematype Segment Device
Fresenius Kabi AG
4R5128
In Commercial Distribution

  • 20810020440533 ()
  • 10810020440536 ()
  • 00810020440539 ()
4R5128

  • Blood collection tube holder, single-use

Alere Determine™ HIV–1/2 Ag/Ab Combo Controls - 10811877010347

The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
Not in Commercial Distribution

  • 10811877010347 ()


  • HIV1/HIV2 antigen/antibody IVD, control

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010323

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2649
Not in Commercial Distribution

  • 10811877010323 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010293

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
Not in Commercial Distribution

  • 10811877010293 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

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

CryoSC-Db Seal positioner - 07640125650570

No Description
Biosafe S.A.
CryoSC-Db Seal positioner
In Commercial Distribution

  • 07640125650570 ()
7035

  • Blood/tissue storage/culture container

CryoSC-D Seal positioner - 07640125650563

No Description
Biosafe S.A.
CryoSC-D Seal positioner
Not in Commercial Distribution

  • 07640125650563 ()
7026

  • Blood/tissue storage/culture container

Insertion Tool - 07640125650556

No Description
Biosafe S.A.
Insertion Tool
Not in Commercial Distribution

  • 07640125650556 ()
  • 07640125650648 ()
7030

  • Blood centrifugation system containment kit

Metal Storage Canister - 07640125650532

No Description
Biosafe S.A.
Metal Storage Canister
In Commercial Distribution

  • 07640125650549 ()
  • 07640125650532 ()
  • 07640125650631 ()
7012

  • Blood/tissue storage/culture container

Overwrap Bag - 07640125650518

No Description
Biosafe S.A.
Overwrap Bag
In Commercial Distribution

  • 07640125650518 ()
  • 07640125650525 ()
4085

  • Blood centrifugation system containment kit

Traceability Labels for Bioarchive - 07640125650501

No Description
Biosafe S.A.
Traceability Labels for Bioarchive
Not in Commercial Distribution

  • 07640125650501 ()
7031

  • Blood centrifugation system containment kit

Traceability Labels for cryopreservation - 07640125650495

No Description
Biosafe S.A.
Traceability Labels for cryopreservation
Not in Commercial Distribution

  • 07640125650495 ()
7011

  • Blood centrifugation system containment kit
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