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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ECMO Reinforced Dual Lumen Cannula, 13F
ORIGEN BIOMEDICAL, INC.
VV13F
Not in Commercial Distribution

  • 10816203022056 ()


  • Mobile extracorporeal gas exchange system catheter kit
Spike extender set, resistant to 80% DMSO, case of 24
ORIGEN BIOMEDICAL, INC.
ST-A
Not in Commercial Distribution

  • 10816203021974 ()
  • 20816203021971 ()


  • Blood transfer set
One spike, vented drip chamber to 9 male luers w/140cm SCD tubing, pinch clamps
ORIGEN BIOMEDICAL, INC.
SDv-9M141
Not in Commercial Distribution

  • 10816203021950 ()
  • 20816203021957 ()


  • Blood transfer set
4-way stopcock, individually pouched, case of 50
ORIGEN BIOMEDICAL, INC.
SC-1
Not in Commercial Distribution

  • 10816203021943 ()
  • 20816203021940 ()


  • Blood transfer set
One spike to one spike with 50cm of SCD tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-S50
Not in Commercial Distribution

  • 10816203021936 ()
  • 20816203021933 ()


  • Blood transfer set
One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F15
Not in Commercial Distribution

  • 10816203021929 ()
  • 20816203021926 ()


  • Blood transfer set
One spike to one 3/8" barb with 12cm DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
S-38B12
In Commercial Distribution

  • 10816203021912 ()
  • 20816203021919 ()


  • Blood transfer set
One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps, case of 20
ORIGEN BIOMEDICAL, INC.
S-FFP12
In Commercial Distribution

  • 10816203021905 ()
  • 20816203021902 ()


  • Blood transfer set
60ml syringe with a cap, double aseptic pouched 20 to a case
ORIGEN BIOMEDICAL, INC.
R60-CS
Not in Commercial Distribution

  • 10816203021899 ()
  • 20816203021896 ()


  • Blood transfer set
12 ml syringe. Double aseptically pouched. 12 per case
ORIGEN BIOMEDICAL, INC.
R12-C
Not in Commercial Distribution

  • 10816203021882 ()
  • 20816203021889 ()


  • Blood transfer set
EVO Bag, 500-2000ml Fill Volume, with one male luer with cap, two female luers with caps, and a needle-free injection port
ORIGEN BIOMEDICAL, INC.
EV3000N
In Commercial Distribution

  • 20816203021865 ()
  • 10816203021868 ()
EV3000N

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 750ml
ORIGEN BIOMEDICAL, INC.
PL750
Not in Commercial Distribution

  • 10816203021851 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 500ml, "P" Set, packed with additional PVC spike port
ORIGEN BIOMEDICAL, INC.
PL500P
Not in Commercial Distribution

  • 10816203021844 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, "K" set
ORIGEN BIOMEDICAL, INC.
PL325K
In Commercial Distribution

  • 10816203021837 ()


  • Blood/tissue storage/culture container
325ml Cell Culture bag, FEP, 4th Generation
ORIGEN BIOMEDICAL, INC.
PL325-4G
In Commercial Distribution

  • 10816203021820 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL30M
In Commercial Distribution

  • 10816203021813 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml Flush Bag, "J" Set, assembled
ORIGEN BIOMEDICAL, INC.
PL30J
Not in Commercial Distribution

  • 10816203021806 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 240ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL240K
In Commercial Distribution

  • 10816203021790 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 2000ml, "P" Set, packed with additional spike port
ORIGEN BIOMEDICAL, INC.
PL2000P
Not in Commercial Distribution

  • 10816203021783 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 2000ml, "P2" Set, packed with additional NFV cover
ORIGEN BIOMEDICAL, INC.
PL2000P2
Not in Commercial Distribution

  • 10816203021776 ()


  • Blood/tissue storage/culture container
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