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

  • 00816203022257 ()
  • 10816203022254 ()


  • 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
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, 19F
ORIGEN BIOMEDICAL, INC.
VV19F
In Commercial Distribution

  • 10816203022094 ()


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

  • 10816203021882 ()
  • 20816203021889 ()


  • Fluid transfer set, general-purpose
PermaLife Cell Culture Bag, 750ml
ORIGEN BIOMEDICAL, INC.
PL750
In Commercial Distribution

  • 10816203021851 ()


  • 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
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, 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, 7ml, "J" Set
ORIGEN BIOMEDICAL, INC.
PL07J
In Commercial Distribution

  • 10816203021745 ()


  • Blood/tissue storage/culture container
Protective Cap for female luer, case of 50
ORIGEN BIOMEDICAL, INC.
PC2-B
In Commercial Distribution

  • 20816203021704 ()
  • 10816203021707 ()


  • Fluid transfer set, general-purpose
Hemofiltration Tubing Set, singly aseptically pouched
ORIGEN BIOMEDICAL, INC.
HFT
In Commercial Distribution

  • 10816203021639 ()


  • Fluid transfer set, general-purpose
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
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750
In Commercial Distribution

  • 20816203021537 ()
  • 10816203021530 ()
  • 00816203021533 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750Y10
In Commercial Distribution

  • 20816203021513 ()
  • 10816203021516 ()
  • 00816203021519 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3
In Commercial Distribution

  • 10816203021493 ()
  • 20816203021490 ()


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 24 x 36 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeute
ORIGEN BIOMEDICAL, INC.
TV2436
In Commercial Distribution

  • 10816203021479 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double pouched
ORIGEN BIOMEDICAL, INC.
CS750M2S
In Commercial Distribution

  • 10816203021455 ()
  • 20816203021452 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 20
ORIGEN BIOMEDICAL, INC.
CS750F5-2
In Commercial Distribution

  • 20816203021438 ()
  • 10816203021431 ()
  • 00816203021434 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, F1 tube set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS750F1S
In Commercial Distribution

  • 10816203021417 ()
  • 20816203021414 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA 4- Bag Set, 10-30ml, "Standard" Tubing Set, 1 set per pouch, case of 6
ORIGEN BIOMEDICAL, INC.
CS50V4
In Commercial Distribution

  • 10816203021387 ()
  • 20816203021384 ()


  • Blood/tissue storage/culture container
Custom 50 EVA 2-Bag set with spikes, 10-30ml, 1 set per pouch, case of 12
ORIGEN BIOMEDICAL, INC.
CS50V2
In Commercial Distribution

  • 10816203021370 ()
  • 20816203021377 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, triply packed
ORIGEN BIOMEDICAL, INC.
CS50S-3
In Commercial Distribution

  • 10816203021356 ()
  • 20816203021353 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, M3 tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution

  • 20816203021339 ()
  • 10816203021332 ()
  • 00816203021335 ()


  • Blood/tissue storage/culture container
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