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 Class Implantable

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Cryostore 500 EVA Freezing Bag, 55 - 100 ml Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500
In Commercial Distribution

  • 20816203021148 ()
  • 10816203021141 ()
  • 00816203021144 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, 4 per triply pouched, 3 pouches per case
ORIGEN BIOMEDICAL, INC.
CS50-3
In Commercial Distribution

  • 20816203021131 ()
  • 10816203021134 ()
  • 00816203021137 ()


  • Blood/tissue storage/culture container
Cryostore 400ml EVA Freezing Bag with standard tube set, 24 per case
ORIGEN BIOMEDICAL, INC.
CS400
In Commercial Distribution

  • 20816203021117 ()
  • 10816203021110 ()
  • 00816203021113 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "Y4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25Y4
In Commercial Distribution

  • 20816203021087 ()
  • 10816203021080 ()
  • 00816203021083 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, 8" donor tube, case of 24
ORIGEN BIOMEDICAL, INC.
CS25XN
In Commercial Distribution

  • 20816203021063 ()
  • 10816203021066 ()
  • 00816203021069 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS25NSW
In Commercial Distribution

  • 10816203021042 ()
  • 20816203021049 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "M5" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25M5
In Commercial Distribution

  • 20816203021025 ()
  • 10816203021028 ()
  • 00816203021021 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "F" tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS25FP
In Commercial Distribution

  • 10816203021011 ()
  • 20816203021018 ()


  • 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" 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, 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, 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 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 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
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
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
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
Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS750Y12S
In Commercial Distribution

  • 10816203020526 ()
  • 20816203020523 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 12, singly packed in triple O-Wrap
ORIGEN BIOMEDICAL, INC.
CS750NSWT
In Commercial Distribution

  • 10816203020502 ()
  • 20816203020509 ()


  • Blood/tissue storage/culture container
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 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double aseptic packed in O-Wrap
ORIGEN BIOMEDICAL, INC.
CS750M2SW
In Commercial Distribution

  • 10816203020465 ()
  • 20816203020462 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, double aseptic packed with OW
ORIGEN BIOMEDICAL, INC.
CS50NSW
In Commercial Distribution

  • 10816203020434 ()
  • 20816203020431 ()


  • Blood/tissue storage/culture container
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 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 12, singly packed in triple OW
ORIGEN BIOMEDICAL, INC.
CS500NSWT
In Commercial Distribution

  • 10816203020397 ()
  • 20816203020394 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, double aseptic pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS500NS
In Commercial Distribution

  • 10816203020373 ()
  • 20816203020370 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500N
In Commercial Distribution

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


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS250Y12S
In Commercial Distribution

  • 10816203020342 ()
  • 20816203020349 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS250NS
In Commercial Distribution

  • 10816203020328 ()
  • 20816203020325 ()


  • Blood/tissue storage/culture container
Cryostore 1950 EVA Freezing Bag, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1950aY8SW
In Commercial Distribution

  • 10816203020298 ()
  • 20816203020295 ()


  • Blood/tissue storage/culture container
One spike to 1 male luer w/50cm SCD tubing & roller clamp
ORIGEN BIOMEDICAL, INC.
SU-M50
In Commercial Distribution

  • 10816203020274 ()
  • 20816203020271 ()


  • Fluid transfer set, general-purpose
PermaLife Cell Culture Bag, 7ml
ORIGEN BIOMEDICAL, INC.
PL07
In Commercial Distribution

  • 10816203020137 ()


  • Blood/tissue storage/culture container
DMSO-Resistant Bag Spike with non- ahdered needle injection port, case of 50
ORIGEN BIOMEDICAL, INC.
IBS-X
In Commercial Distribution

  • 10816203020113 ()
  • 20816203020110 ()


  • Intravenous fluid bag spike
DMSO-Resistant Bag Spike with needle injection port, case of 50
ORIGEN BIOMEDICAL, INC.
IBS
In Commercial Distribution

  • 10816203020106 ()
  • 20816203020103 ()


  • Intravenous fluid bag spike
Two spikes to a 3-way stopcock, 60ml syringe and needle-free valve to four male luers with 70cm SCD tubing and pinch clamps.
ORIGEN BIOMEDICAL, INC.
CC1
In Commercial Distribution

  • 20816203020059 ()
  • 10816203020052 ()


  • Intravenous fluid bag spike
Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps
ORIGEN BIOMEDICAL, INC.
4S-4M60
In Commercial Distribution

  • 10816203020038 ()
  • 20816203020035 ()


  • Intravenous fluid bag spike
Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a spike port, and a CS25 for final freezing of product
ORIGEN BIOMEDICAL, INC.
10-200-CS25
Not in Commercial Distribution

  • 20816203023296 ()
  • 10816203023299 ()


  • Blood washing/centrifugation bag
Two 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port
ORIGEN BIOMEDICAL, INC.
10-200-2
Not in Commercial Distribution

  • 20816203023289 ()
  • 10816203023282 ()


  • Blood washing/centrifugation bag
One 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port
ORIGEN BIOMEDICAL, INC.
10-200
Not in Commercial Distribution

  • 20816203023272 ()
  • 10816203023275 ()
  • 00816203023278 ()


  • Blood washing/centrifugation bag
Two spikes to nine male luers with 140cm SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
2S-9M141
Not in Commercial Distribution

  • 20816203023265 ()
  • 10816203023268 ()


  • Fluid transfer set, general-purpose
Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes
ORIGEN BIOMEDICAL, INC.
PCT
Not in Commercial Distribution

  • 10816203023145 ()


  • Vascular catheter introduction set, nonimplantable
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
Not in Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


  • Fluid transfer set, general-purpose
O-Wrap overwrap 3-layer pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430T
Not in Commercial Distribution

  • 00816203022202 ()
  • 10816203022209 ()


  • Blood/tissue storage/culture container
Adapter tube set, 4 bag spikes x 1 Male luer, 40cm
ORIGEN BIOMEDICAL, INC.
4S-M40
Not in Commercial Distribution

  • 10816203022193 ()
  • 20816203022190 ()


  • Blood transfer set
Cryobag, 19 x 36, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1936
Not in Commercial Distribution

  • 10816203020694 ()


  • Blood/tissue storage/culture container
Cryobag, 09x15, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB0915
Not in Commercial Distribution

  • 10816203020656 ()


  • Blood/tissue storage/culture container
Two male luers to one male luer with 17cm of DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
2M-M17
Not in Commercial Distribution

  • 10816203020601 ()
  • 20816203020608 ()


  • Fluid transfer set, general-purpose
One spike to one male luer with 150cm tubing and roller clamp
ORIGEN BIOMEDICAL, INC.
150-S-M
Not in Commercial Distribution

  • 10816203020588 ()
  • 20816203020585 ()


  • Fluid transfer set, general-purpose
One female luer to one male luer with 12cm DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
12-F-M
Not in Commercial Distribution

  • 10816203020557 ()
  • 20816203020554 ()


  • Fluid transfer set, general-purpose
4x12cm SCD tubing tube set
ORIGEN BIOMEDICAL, INC.
24-T-3T
Not in Commercial Distribution

  • 10816203020014 ()
  • 20816203020011 ()


  • Fluid transfer set, general-purpose
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