Company Name Brand Name GMDN Term FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Class Implantable

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PermaLife Cell Culture Bag, 120ml, with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution

  • 10816203021769 ()
  • 00816203021762 ()


  • Patient-washing mitten
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y11" Tubing Set, case of 50
ORIGEN BIOMEDICAL, INC.
CS750Y11
In Commercial Distribution

  • 20816203021520 ()
  • 10816203021523 ()
  • 00816203021526 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750Y10
In Commercial Distribution

  • 20816203021513 ()
  • 10816203021516 ()
  • 00816203021519 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA 3-Bag set with drip spikes, 80-190ml, case of 6 sets
ORIGEN BIOMEDICAL, INC.
CS750V4
In Commercial Distribution

  • 10816203021509 ()
  • 20816203021506 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3
In Commercial Distribution

  • 10816203021493 ()
  • 20816203021490 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double pouched
ORIGEN BIOMEDICAL, INC.
CS750M2S
In Commercial Distribution

  • 10816203021455 ()
  • 20816203021452 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F8" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F8
In Commercial Distribution

  • 20816203021445 ()
  • 10816203021448 ()
  • 00816203021441 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 20
ORIGEN BIOMEDICAL, INC.
CS750F5-2
In Commercial Distribution

  • 20816203021438 ()
  • 10816203021431 ()
  • 00816203021434 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F5
In Commercial Distribution

  • 20816203021421 ()
  • 10816203021424 ()
  • 00816203021427 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, F1 tube set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS750F1S
In Commercial Distribution

  • 10816203021417 ()
  • 20816203021414 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "Y3" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50Y3
In Commercial Distribution

  • 20816203021407 ()
  • 10816203021400 ()
  • 00816203021403 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA 4- Bag Set, 10-30ml, "Standard" Tubing Set, 1 set per pouch, case of 6
ORIGEN BIOMEDICAL, INC.
CS50V4
In Commercial Distribution

  • 10816203021387 ()
  • 20816203021384 ()


  • Blood/tissue storage/culture container
Custom 50 EVA 2-Bag set with spikes, 10-30ml, 1 set per pouch, case of 12
ORIGEN BIOMEDICAL, INC.
CS50V2
In Commercial Distribution

  • 10816203021370 ()
  • 20816203021377 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS50SW
In Commercial Distribution

  • 10816203021363 ()
  • 20816203021360 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, triply packed
ORIGEN BIOMEDICAL, INC.
CS50S-3
In Commercial Distribution

  • 10816203021356 ()
  • 20816203021353 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS50S
In Commercial Distribution

  • 10816203021349 ()
  • 20816203021346 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, M3 tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution

  • 20816203021339 ()
  • 10816203021332 ()
  • 00816203021335 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24, heat sealed
ORIGEN BIOMEDICAL, INC.
CS50H
In Commercial Distribution

  • 20816203021322 ()
  • 10816203021325 ()
  • 00816203021328 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10-30ml, "F4" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS50F4S
In Commercial Distribution

  • 10816203021318 ()
  • 20816203021315 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10-30ml, "F15" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50F15
In Commercial Distribution

  • 20816203021278 ()
  • 10816203021271 ()
  • 00816203021274 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 12, singly packed in triple OW
ORIGEN BIOMEDICAL, INC.
CS250NSWT
In Commercial Distribution

  • 10816203020953 ()
  • 20816203020950 ()


  • Blood/tissue storage/culture container
Cryostore 400 Conical EVA Freezing Bag 60-135ml, "Y9" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CSD400Y9
In Commercial Distribution

  • 20816203020936 ()
  • 10816203020939 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing bag, 30-70ml with F7 Tube Set
ORIGEN BIOMEDICAL, INC.
CS250F7P
In Commercial Distribution

  • 10816203020915 ()
  • 20816203020912 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F5" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F5
In Commercial Distribution

  • 20816203020899 ()
  • 10816203020892 ()
  • 00816203020895 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F4
In Commercial Distribution

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


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 250ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1
In Commercial Distribution

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


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y5" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000Y5
In Commercial Distribution

  • 10816203020816 ()
  • 20816203020813 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450ml, "N" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000NS
In Commercial Distribution

  • 10816203020809 ()
  • 20816203020806 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450 ml, "N" Tubing Set, singly pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000NP
In Commercial Distribution

  • 10816203020793 ()
  • 20816203020790 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450 ml, "N" Tube Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000N
In Commercial Distribution

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


  • Blood/tissue storage/culture container
Cryostore 1000 EVA Freezing Bag, "Y4" Tubing Set, one bag per pouch, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000Y4S
In Commercial Distribution

  • 10816203020779 ()
  • 20816203020776 ()


  • Blood/tissue storage/culture container
CryoStore 1000 EVA Freezing Bag, 3-bag Set, 120 - 275 ml, "V4" Tube Set, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS1000V4
In Commercial Distribution

  • 10816203020762 ()
  • 20816203020769 ()


  • Blood/tissue storage/culture container
CryoStore 1000 EVA Freezing Bag, 3-bag Set, 120 - 275 ml, "V3" Tube Set, case of 12 sets
ORIGEN BIOMEDICAL, INC.
CS1000V3
In Commercial Distribution

  • 10816203020755 ()
  • 20816203020752 ()


  • Blood/tissue storage/culture container
Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000NSW
In Commercial Distribution

  • 10816203020748 ()
  • 20816203020745 ()


  • Blood/tissue storage/culture container
Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000NS
In Commercial Distribution

  • 10816203020731 ()
  • 20816203020738 ()


  • Blood/tissue storage/culture container
Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS1000N
In Commercial Distribution

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


  • Blood/tissue storage/culture container
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
In Commercial Distribution

  • 20816203020714 ()
  • 10816203020717 ()


  • Blood/tissue storage/culture container
Cryobag, 14 x 28, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1428
In Commercial Distribution

  • 10816203020700 ()


  • Blood/tissue storage/culture container
Cryobag, 19 x 36, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1936
In Commercial Distribution

  • 10816203020694 ()


  • Blood/tissue storage/culture container
Cryobag, 14 x 20, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1420
In Commercial Distribution

  • 10816203020687 ()
  • 00816203020680 ()


  • Blood/tissue storage/culture container
Cryobag, 10x16, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1016
In Commercial Distribution

  • 10816203020663 ()


  • Blood/tissue storage/culture container
Cryobag, 09x15, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB0915
In Commercial Distribution

  • 10816203020656 ()


  • Blood/tissue storage/culture container
One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps
ORIGEN BIOMEDICAL, INC.
40-S-V-SMM
In Commercial Distribution

  • 10816203020632 ()
  • 20816203020639 ()


  • Intravenous fluid bag spike
Three spikes to sealed tubing with 100cm of SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
3S-T100
In Commercial Distribution

  • 10816203020625 ()
  • 20816203020622 ()


  • Intravenous fluid bag spike
Two spike ports to one spike with 16cm SCD tubing
ORIGEN BIOMEDICAL, INC.
2P-S16
In Commercial Distribution

  • 20816203020615 ()
  • 10816203020618 ()


  • Intravenous fluid bag spike
Two male luers to one male luer with 17cm of DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
2M-M17
In Commercial Distribution

  • 10816203020601 ()
  • 20816203020608 ()


  • Fluid transfer set, general-purpose
Two male luers to one female luer with 17cm of DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
2M-F17
In Commercial Distribution

  • 10816203020595 ()
  • 20816203020592 ()


  • Fluid transfer set, general-purpose
One spike to one male luer with 150cm tubing and roller clamp
ORIGEN BIOMEDICAL, INC.
150-S-M
In Commercial Distribution

  • 10816203020588 ()
  • 20816203020585 ()


  • Fluid transfer set, general-purpose
60ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF60-T
In Commercial Distribution

  • 10816203020571 ()
  • 20816203020578 ()


  • Fluid transfer set, general-purpose
3ml BD syringe on a female luer with 15cm of SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R3FT
In Commercial Distribution

  • 10816203020564 ()
  • 20816203020561 ()


  • Fluid transfer set, general-purpose
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