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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PermaLife Cell Culture Bag, 120ml, with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution

  • 10816203021769 ()
  • 00816203021762 ()


  • Patient-washing mitten
CryoStore 750 EVA Freezing Bag, 80-190ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS750KS
In Commercial Distribution

  • 20816203023746 ()
  • 10816203023749 ()
CS750KS

  • Blood/tissue storage/culture container
CryoStore 500 EVA Freezing Bag, 55 - 100ml "K" Tube Set, double aseptically packed.
ORIGEN BIOMEDICAL, INC.
CS500KS
In Commercial Distribution

  • 20816203023739 ()
  • 10816203023732 ()
CS500KS

  • Blood/tissue storage/culture container
CryoStore 50 EVA Freezing Bag,10-30ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS50KS
In Commercial Distribution

  • 20816203023722 ()
  • 10816203023725 ()
CS50KS

  • Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250S
In Commercial Distribution

  • 20816203023647 ()
  • 10816203023640 ()
CS250S

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 750ml, with tubing
ORIGEN BIOMEDICAL, INC.
PL750T
In Commercial Distribution

  • 20816203023630 ()
  • 10816203023633 ()
PL750T

  • Blood/tissue storage/culture container
One female luer to 9 male luers, 45cm PVC tubing, with pinch clamps
ORIGEN BIOMEDICAL, INC.
45-F-9M
In Commercial Distribution

  • 20816203023197 ()
  • 10816203023190 ()
45-F-9M

  • 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
One 0.2um filter to sealed SCD tubing, sterile
ORIGEN BIOMEDICAL, INC.
15-T-FA
In Commercial Distribution

  • 20816203023067 ()
  • 10816203023060 ()


  • Fluid transfer set, general-purpose
20ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF20-T
In Commercial Distribution

  • 20816203023050 ()
  • 10816203023053 ()


  • Fluid transfer set, general-purpose
12ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF12-T
In Commercial Distribution

  • 20816203023043 ()
  • 10816203023046 ()


  • Fluid transfer set, general-purpose
PermaLife Cell Culture Bag, 325ml with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325M
In Commercial Distribution

  • 10816203023008 ()
PL325M

  • 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 28 EVA Freezing Bag, 5-20 ml, F tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS28F
In Commercial Distribution

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


  • Blood/tissue storage/culture container
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
One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50C
In Commercial Distribution

  • 10816203022469 ()
  • 20816203022466 ()


  • Fluid transfer set, general-purpose
Spike port to six male luers. Singly pouched, 12 per case.
ORIGEN BIOMEDICAL, INC.
30-P-6M
In Commercial Distribution

  • 20816203022435 ()
  • 10816203022438 ()


  • Intravenous fluid bag spike
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 ()


  • Fluid transfer set, general-purpose
PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
In Commercial Distribution

  • 10816203022377 ()


  • Blood/tissue storage/culture container
One spike to one female luer with 12cm SCD Tubing, case of 50
ORIGEN BIOMEDICAL, INC.
F-S12
In Commercial Distribution

  • 10816203022339 ()
  • 20816203022336 ()


  • Fluid transfer set, general-purpose
One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptically pouched, case of 50
ORIGEN BIOMEDICAL, INC.
F-M12
In Commercial Distribution

  • 10816203022322 ()
  • 20816203022329 ()


  • Fluid transfer set, general-purpose
Cryostore 2000 EVA Freezing Bag, 4-bag Set, 180-450ml, "V8" Tubing Set, double aseptically pouched.
ORIGEN BIOMEDICAL, INC.
CS2000V8S
In Commercial Distribution

  • 20816203022299 ()
  • 10816203022292 ()


  • Blood/tissue storage/culture container
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
RBC tube set, sealed tube with spike, FLL, and spike port
ORIGEN BIOMEDICAL, INC.
30-T-SPF
In Commercial Distribution

  • 20816203022183 ()
  • 10816203022186 ()


  • Intravenous fluid bag spike
ECMO Reinforced Dual Lumen Cannula, 32F
ORIGEN BIOMEDICAL, INC.
VV32F
In Commercial Distribution

  • 10816203022148 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 28F
ORIGEN BIOMEDICAL, INC.
VV28F
In Commercial Distribution

  • 10816203022124 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 23F
ORIGEN BIOMEDICAL, INC.
VV23F
In Commercial Distribution

  • 10816203022100 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 19F
ORIGEN BIOMEDICAL, INC.
VV19F
In Commercial Distribution

  • 10816203022094 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 16F
ORIGEN BIOMEDICAL, INC.
VV16F
In Commercial Distribution

  • 10816203022070 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 13F
ORIGEN BIOMEDICAL, INC.
VV13F
In Commercial Distribution

  • 10816203022056 ()


  • Mobile extracorporeal gas exchange system catheter kit
Two 4-way stopcocks adhesive bonded
ORIGEN BIOMEDICAL, INC.
SC-2
In Commercial Distribution

  • 20816203022046 ()
  • 10816203022049 ()


  • Fluid transfer set, general-purpose
Spike extender set, resistant to 80% DMSO, case of 24
ORIGEN BIOMEDICAL, INC.
ST-A
In Commercial Distribution

  • 10816203021974 ()
  • 20816203021971 ()


  • Fluid transfer set, general-purpose
One spike with male to male luer, case of 50
ORIGEN BIOMEDICAL, INC.
SM
In Commercial Distribution

  • 10816203021967 ()
  • 20816203021964 ()


  • Fluid transfer set, general-purpose
One spike, vented drip chamber to 9 male luers w/140cm SCD tubing, pinch clamps
ORIGEN BIOMEDICAL, INC.
SDv-9M141
In Commercial Distribution

  • 10816203021950 ()
  • 20816203021957 ()


  • Fluid transfer set, general-purpose
4-way stopcock, individually pouched, case of 50
ORIGEN BIOMEDICAL, INC.
SC-1
In Commercial Distribution

  • 10816203021943 ()
  • 20816203021940 ()


  • Fluid transfer set, general-purpose
One spike to one spike with 50cm of SCD tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-S50
In Commercial Distribution

  • 10816203021936 ()
  • 20816203021933 ()


  • Fluid transfer set, general-purpose
60ml syringe with a cap, double aseptic pouched 20 to a case
ORIGEN BIOMEDICAL, INC.
R60-CS
In Commercial Distribution

  • 10816203021899 ()
  • 20816203021896 ()


  • Fluid transfer set, general-purpose
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, 500ml, "P" Set, packed with additional PVC spike port
ORIGEN BIOMEDICAL, INC.
PL500P
In Commercial Distribution

  • 10816203021844 ()


  • 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 Flush Bag, "J" Set, assembled
ORIGEN BIOMEDICAL, INC.
PL30J
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
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
In Commercial Distribution

  • 10816203021776 ()


  • Blood/tissue storage/culture container
One female luer to eight spikes with 100cm of SCD tubing and pinch clamps, case of 20
ORIGEN BIOMEDICAL, INC.
F-8S100
In Commercial Distribution

  • 10816203021615 ()
  • 20816203021612 ()


  • Intravenous fluid bag spike
Evolve Tissue Culture Bag, 120ml, case of 20
ORIGEN BIOMEDICAL, INC.
EV120
In Commercial Distribution

  • 10816203021592 ()
  • 20816203021599 ()


  • Blood/tissue storage/culture container
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