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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Cryobag, 14 x 20, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1420
In Commercial Distribution

  • 10816203020687 ()
  • 00816203020680 ()


  • Blood/tissue storage/culture container
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
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
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, double aseptic packed in O-Wrap
ORIGEN BIOMEDICAL, INC.
CS750NSW
In Commercial Distribution

  • 10816203020496 ()
  • 20816203020493 ()


  • Blood/tissue storage/culture container
CryoBag with ports, 10ml Kapton and FEP bag
ORIGEN BIOMEDICAL, INC.
CB10K2
In Commercial Distribution

  • 10816203020472 ()


  • 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" 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 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, "N" tube set, case of 12, double aseptic packed in OW
ORIGEN BIOMEDICAL, INC.
CS250NSW
In Commercial Distribution

  • 10816203020335 ()
  • 20816203020332 ()


  • 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
Vial spike with needle-free valve, pack of 10
ORIGEN BIOMEDICAL, INC.
VSV
In Commercial Distribution

  • 20816203020288 ()
  • 10816203020281 ()


  • Fluid transfer set, general-purpose
One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50
In Commercial Distribution

  • 20816203020264 ()
  • 10816203020267 ()


  • Fluid transfer set, general-purpose
One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F10
In Commercial Distribution

  • 10816203020236 ()
  • 20816203020233 ()


  • Fluid transfer set, general-purpose
6ml syringe on a needle-free valve with 15cm SCD tubing with porous vent plug , case of 25
ORIGEN BIOMEDICAL, INC.
RV-T15
In Commercial Distribution

  • 10816203020229 ()
  • 20816203020226 ()


  • Fluid transfer set, general-purpose
6ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
RF-T15
In Commercial Distribution

  • 10816203020205 ()
  • 20816203020202 ()


  • Fluid transfer set, general-purpose
PermaLife Cell Culture Bag, 70ml
ORIGEN BIOMEDICAL, INC.
PL70
In Commercial Distribution

  • 10816203020182 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml
ORIGEN BIOMEDICAL, INC.
PL325
In Commercial Distribution

  • 10816203020175 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml
ORIGEN BIOMEDICAL, INC.
PL30
In Commercial Distribution

  • 10816203020168 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 240ml
ORIGEN BIOMEDICAL, INC.
PL240
In Commercial Distribution

  • 10816203020151 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml
ORIGEN BIOMEDICAL, INC.
PL120
In Commercial Distribution

  • 10816203020144 ()


  • Blood/tissue storage/culture container
120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm in length
ORIGEN BIOMEDICAL, INC.
EV120 + F-M12
In Commercial Distribution

  • 10816203020090 ()
  • 20816203020097 ()


  • Blood/tissue storage/culture container
One spike and male luer 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.
CC2
In Commercial Distribution

  • 20816203020066 ()
  • 10816203020069 ()


  • Intravenous fluid bag spike
DMSO resistant Bag Spike w/ Needle-Free Injection Port
ORIGEN BIOMEDICAL, INC.
CBS
In Commercial Distribution

  • 10816203020045 ()
  • 20816203020042 ()


  • Intravenous fluid bag spike
Two spikes to one spike port with 20cm SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
2S-P20
In Commercial Distribution

  • 10816203020021 ()
  • 20816203020028 ()


  • Intravenous fluid bag spike
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