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 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched
ORIGEN BIOMEDICAL, INC.
80HAS
Not in Commercial Distribution

  • 10816203024197 ()
  • 20816203024194 ()
80HAS

  • Blood transfer set
Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps
ORIGEN BIOMEDICAL, INC.
4S-4M60
Not in Commercial Distribution

  • 10816203024180 ()
4S-4M60

  • Blood transfer set
PermaLife Cell Culture Bag, 70 mL - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL70-2G
Not in Commercial Distribution

  • 20816203024125 ()
  • 10816203024128 ()
PL70-2G

  • Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set, singly packed
ORIGEN BIOMEDICAL, INC.
CS25FP
Not in Commercial Distribution

  • 20816203023906 ()
  • 10816203023909 ()
CS25FP

  • Blood/tissue storage/culture container
20ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF20-T
Not in Commercial Distribution

  • 20816203023883 ()
  • 10816203023886 ()
15-RF20-T

  • Blood transfer set
6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R6F-TA
Not in Commercial Distribution

  • 20816203023869 ()
  • 10816203023862 ()
15-R6F-TA

  • Blood transfer set
Needle-free vial spike, DMSO-resistant
ORIGEN BIOMEDICAL, INC.
VSV
Not in Commercial Distribution

  • 20816203023845 ()
  • 10816203023848 ()
VSV

  • Fluid transfer set, general-purpose
6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R6F-TA
In Commercial Distribution

  • 20816203023449 ()
  • 10816203023442 ()
15-R6F-TA

  • Blood transfer set
Cryostore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, singly packed
ORIGEN BIOMEDICAL, INC.
CS500NP
Not in Commercial Distribution

  • 20816203023425 ()
  • 10816203023428 ()
CS500NP

  • Blood/tissue storage/culture container
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
20ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF20-T
In Commercial Distribution

  • 20816203023050 ()
  • 10816203023053 ()


  • Blood transfer set
PermaLife Cell Culture Bag, 325ml, "P" Set, packed with additional PVC spike port
ORIGEN BIOMEDICAL, INC.
PL325P
Not in Commercial Distribution

  • 10816203023015 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325M
In Commercial Distribution

  • 10816203023008 ()
PL325M

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, "L" Set with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325L
Not in Commercial Distribution

  • 10816203022995 ()


  • Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250N
In Commercial Distribution

  • 10816203022889 ()
  • 00816203022882 ()
  • 20816203022886 ()
CS250N

  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750N
In Commercial Distribution

  • 10816203022865 ()
  • 00816203022868 ()
  • 20816203022862 ()


  • Blood/tissue storage/culture container
Cryostore 28 EVA Freezing Bag, 5-20 ml, F tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS28F
Not in Commercial Distribution

  • 10816203022841 ()
  • 20816203022848 ()
  • 00816203022844 ()


  • Blood/tissue storage/culture container
One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched
ORIGEN BIOMEDICAL, INC.
80HAS
In Commercial Distribution

  • 20816203022824 ()
  • 10816203022827 ()
80HAS

  • Blood transfer set
TissueVault, Cell and Tissue Freezing 19x50cm bag
ORIGEN BIOMEDICAL, INC.
TV1950
In Commercial Distribution

  • 10816203022810 ()
TV1950

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 14x30cm bag
ORIGEN BIOMEDICAL, INC.
TV1430
In Commercial Distribution

  • 10816203022803 ()
TV1430

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 9x18cm bag
ORIGEN BIOMEDICAL, INC.
TV0918
In Commercial Distribution

  • 10816203022797 ()
TV0918

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 9x9cm bag
ORIGEN BIOMEDICAL, INC.
TV0909
In Commercial Distribution

  • 10816203022780 ()
TV0909

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing,19x36cm
ORIGEN BIOMEDICAL, INC.
OW1936
In Commercial Distribution

  • 00816203022615 ()
  • 10816203022612 ()
OW1936

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430
In Commercial Distribution

  • 00816203022608 ()
  • 10816203022605 ()
OW1430

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x18cm
ORIGEN BIOMEDICAL, INC.
OW0918
In Commercial Distribution

  • 00816203022592 ()
  • 10816203022599 ()
OW0918

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x9cm.
ORIGEN BIOMEDICAL, INC.
OW0909
In Commercial Distribution

  • 00816203022585 ()
  • 10816203022582 ()
OW0909

  • Blood/tissue storage/culture container
One spike to one spike with 10cm of SCD tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-S10
In Commercial Distribution

  • 10816203022384 ()
  • 20816203022381 ()


  • Blood transfer set
One spike to one female luer with 12cm SCD Tubing, case of 50
ORIGEN BIOMEDICAL, INC.
F-S12
Not in Commercial Distribution

  • 10816203022339 ()
  • 20816203022336 ()


  • Blood transfer set
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
RBC tube set, sealed tube with spike, FLL, and spike port
ORIGEN BIOMEDICAL, INC.
30-T-SPF
Not in Commercial Distribution

  • 20816203022183 ()
  • 10816203022186 ()


  • Blood transfer set
ECMO Reinforced Dual Lumen Cannula, 32F
ORIGEN BIOMEDICAL, INC.
VV32F
Not in Commercial Distribution

  • 10816203022148 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 28F
ORIGEN BIOMEDICAL, INC.
VV28F
Not in Commercial Distribution

  • 10816203022124 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 19F
ORIGEN BIOMEDICAL, INC.
VV19F
Not in Commercial Distribution

  • 10816203022094 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 16F
ORIGEN BIOMEDICAL, INC.
VV16F
Not in Commercial Distribution

  • 10816203022070 ()


  • Mobile extracorporeal gas exchange system catheter kit
Two 4-way stopcocks adhesive bonded
ORIGEN BIOMEDICAL, INC.
SC-2
Not in Commercial Distribution

  • 20816203022046 ()
  • 10816203022049 ()


  • Blood transfer set
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 with male to male luer, case of 50
ORIGEN BIOMEDICAL, INC.
SM
Not in Commercial Distribution

  • 10816203021967 ()
  • 20816203021964 ()


  • 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
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