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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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 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 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 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, double aseptically pouched, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3S
In Commercial Distribution

  • 10816203020519 ()
  • 20816203020516 ()


  • 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" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750M2
In Commercial Distribution

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


  • 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" 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, double aseptic pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS500NS
In Commercial Distribution

  • 10816203020373 ()
  • 20816203020370 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution

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


  • 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
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
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 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F50
In Commercial Distribution

  • 10816203020243 ()
  • 20816203020240 ()


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

  • 10816203020106 ()
  • 20816203020103 ()


  • 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 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
One female luer with 15cm of SCD tubing, case of 50
ORIGEN BIOMEDICAL, INC.
15-F-T
In Commercial Distribution

  • 10816203020007 ()
  • 20816203020004 ()


  • Fluid transfer set, general-purpose
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
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