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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Four spikes 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.
CC3
Not in Commercial Distribution

  • 20816203023319 ()
  • 10816203023312 ()
CC3

  • Blood transfer set
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
O-Wrap, overwrap pouch for freezing, 4X19cm
ORIGEN BIOMEDICAL, INC.
OW0419
Not in Commercial Distribution

  • 10816203022575 ()
  • 00816203022578 ()


  • 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
Not 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
Not in Commercial Distribution

  • 20816203022435 ()
  • 10816203022438 ()


  • Blood transfer set
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
Not 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
Not 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
Not 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
Not in Commercial Distribution

  • 20816203022299 ()
  • 10816203022292 ()


  • Blood/tissue storage/culture container
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
Not in Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


  • Blood transfer set
O-Wrap, overwrap pouch for freezing, 24x36cm
ORIGEN BIOMEDICAL, INC.
OW2436
In Commercial Distribution

  • 00816203022257 ()
  • 10816203022254 ()
OW2436

  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1A
Not in Commercial Distribution

  • 20816203022244 ()
  • 10816203022247 ()
  • 00816203022240 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450ml, "Standard" Tube Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000
Not in Commercial Distribution

  • 10816203022230 ()
  • 20816203022237 ()
  • 00816203022233 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing,19x50cm
ORIGEN BIOMEDICAL, INC.
OW1950
In Commercial Distribution

  • 00816203022226 ()
  • 10816203022223 ()
OW1950

  • 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
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, 23F
ORIGEN BIOMEDICAL, INC.
VV23F
Not in Commercial Distribution

  • 10816203022100 ()


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

  • 10816203022056 ()


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

  • 10816203021974 ()
  • 20816203021971 ()


  • Fluid transfer set, general-purpose
One spike with male to male luer, case of 50
ORIGEN BIOMEDICAL, INC.
SM
Not 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
Not in Commercial Distribution

  • 10816203021950 ()
  • 20816203021957 ()


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

  • 10816203021936 ()
  • 20816203021933 ()


  • Fluid transfer set, general-purpose
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 ()


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

  • 10816203021912 ()
  • 20816203021919 ()


  • Fluid transfer set, general-purpose
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 ()


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

  • 10816203021899 ()
  • 20816203021896 ()


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

  • 10816203021882 ()
  • 20816203021889 ()


  • 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, 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
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