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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Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes
ORIGEN BIOMEDICAL, INC.
PCT
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, "P" Set, packed with additional PVC spike port
ORIGEN BIOMEDICAL, INC.
PL325P
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 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, "L" Set with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325L
In Commercial Distribution

  • 10816203022995 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250N
In Commercial Distribution

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


  • 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
In Commercial Distribution

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


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 19 x 50 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV1950
In Commercial Distribution

  • 10816203022810 ()


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 14 x 30 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV1430
In Commercial Distribution

  • 10816203022803 ()


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 9 x 18 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV0918
In Commercial Distribution

  • 10816203022797 ()


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 9 x 9 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV0909
In Commercial Distribution

  • 10816203022780 ()


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

  • 00816203022615 ()
  • 10816203022612 ()


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

  • 00816203022608 ()
  • 10816203022605 ()


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

  • 00816203022592 ()
  • 10816203022599 ()


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

  • 00816203022585 ()
  • 10816203022582 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 4X19cm
ORIGEN BIOMEDICAL, INC.
OW0419
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
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
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
In Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


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

  • 00816203022257 ()
  • 10816203022254 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1A
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
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 ()


  • Blood/tissue storage/culture container
O-Wrap overwrap 3-layer pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430T
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
In Commercial Distribution

  • 10816203022193 ()
  • 20816203022190 ()


  • Intravenous fluid bag spike
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
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, 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
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
One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F15
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
In Commercial Distribution

  • 10816203021899 ()
  • 20816203021896 ()


  • Fluid transfer set, general-purpose
12 ml syringe. Double aseptically pouched. 12 per case
ORIGEN BIOMEDICAL, INC.
R12-C
In Commercial Distribution

  • 10816203021882 ()
  • 20816203021889 ()


  • Fluid transfer set, general-purpose
Evolve Tissue Culture Bag, 500-2000ml, "N" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
EV3000N
In Commercial Distribution

  • 20816203021865 ()
  • 10816203021868 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 750ml
ORIGEN BIOMEDICAL, INC.
PL750
In Commercial Distribution

  • 10816203021851 ()


  • Blood/tissue storage/culture container
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