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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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
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, 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, 16F
ORIGEN BIOMEDICAL, INC.
VV16F
In Commercial Distribution

  • 10816203022070 ()


  • 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
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
PermaLife Cell Culture Bag, 7ml, "J" Set
ORIGEN BIOMEDICAL, INC.
PL07J
In Commercial Distribution

  • 10816203021745 ()


  • Blood/tissue storage/culture container
Percutaneous Introducer Kit, singly aspetically pouched
ORIGEN BIOMEDICAL, INC.
PCTa
In Commercial Distribution

  • 10816203021721 ()


  • Vascular catheter introduction set, nonimplantable
DMSO-Resistant Bag Spike with needle injection port , bulk packed
ORIGEN BIOMEDICAL, INC.
IBS-B
In Commercial Distribution

  • 10816203021646 ()
  • 20816203021643 ()


  • Intravenous fluid bag spike
Female to female luer adapter
ORIGEN BIOMEDICAL, INC.
F2F
In Commercial Distribution

  • 10816203021622 ()
  • 20816203021629 ()


  • Fluid transfer set, general-purpose
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24, heat sealed
ORIGEN BIOMEDICAL, INC.
CS50H
In Commercial Distribution

  • 20816203021322 ()
  • 10816203021325 ()
  • 00816203021328 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10-30ml, "F15" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50F15
In Commercial Distribution

  • 20816203021278 ()
  • 10816203021271 ()
  • 00816203021274 ()


  • Blood/tissue storage/culture container
Custom 500ml EVA 2-bag set with spikes, 1 set per pouch, 12 sets per case
ORIGEN BIOMEDICAL, INC.
CS500V2P
In Commercial Distribution

  • 10816203021257 ()
  • 20816203021254 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS500SW
In Commercial Distribution

  • 10816203021233 ()
  • 20816203021230 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
In Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, custom length, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i3
In Commercial Distribution

  • 20816203021209 ()
  • 10816203021202 ()
  • 00816203021205 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2
In Commercial Distribution

  • 10816203021189 ()
  • 20816203021186 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F1" Tubing Set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS500F1S
In Commercial Distribution

  • 10816203021165 ()
  • 20816203021162 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500
In Commercial Distribution

  • 20816203021148 ()
  • 10816203021141 ()
  • 00816203021144 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, 4 per triply pouched, 3 pouches per case
ORIGEN BIOMEDICAL, INC.
CS50-3
In Commercial Distribution

  • 20816203021131 ()
  • 10816203021134 ()
  • 00816203021137 ()


  • Blood/tissue storage/culture container
Cryostore 400ml EVA Freezing Bag with standard tube set, 24 per case
ORIGEN BIOMEDICAL, INC.
CS400
In Commercial Distribution

  • 20816203021117 ()
  • 10816203021110 ()
  • 00816203021113 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "Y4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25Y4
In Commercial Distribution

  • 20816203021087 ()
  • 10816203021080 ()
  • 00816203021083 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, 8" donor tube, case of 24
ORIGEN BIOMEDICAL, INC.
CS25XN
In Commercial Distribution

  • 20816203021063 ()
  • 10816203021066 ()
  • 00816203021069 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS25NSW
In Commercial Distribution

  • 10816203021042 ()
  • 20816203021049 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "M5" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25M5
In Commercial Distribution

  • 20816203021025 ()
  • 10816203021028 ()
  • 00816203021021 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "F" tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS25FP
In Commercial Distribution

  • 10816203021011 ()
  • 20816203021018 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450ml, "N" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000NS
In Commercial Distribution

  • 10816203020809 ()
  • 20816203020806 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450 ml, "N" Tube Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000N
In Commercial Distribution

  • 20816203020783 ()
  • 10816203020786 ()
  • 00816203020789 ()


  • Blood/tissue storage/culture container
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