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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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
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
O-Wrap, overwrap pouch for freezing,19x50cm
ORIGEN BIOMEDICAL, INC.
OW1950
In Commercial Distribution

  • 00816203022226 ()
  • 10816203022223 ()
OW1950

  • 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
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, 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
Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
Not in Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container
Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000NS
Not in Commercial Distribution

  • 10816203020731 ()
  • 20816203020738 ()


  • Blood/tissue storage/culture container
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