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 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500N
In Commercial Distribution

  • 20816203020363 ()
  • 10816203020366 ()
  • 00816203020369 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution

  • 20816203020356 ()
  • 10816203020359 ()
  • 00816203020352 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS250Y12S
In Commercial Distribution

  • 10816203020342 ()
  • 20816203020349 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" tube set, case of 12, double aseptic packed in OW
ORIGEN BIOMEDICAL, INC.
CS250NSW
In Commercial Distribution

  • 10816203020335 ()
  • 20816203020332 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS250NS
In Commercial Distribution

  • 10816203020328 ()
  • 20816203020325 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000aY8SW
In Commercial Distribution

  • 10816203020304 ()
  • 20816203020301 ()


  • Blood/tissue storage/culture container
Cryostore 1950 EVA Freezing Bag, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1950aY8SW
In Commercial Distribution

  • 10816203020298 ()
  • 20816203020295 ()


  • Blood/tissue storage/culture container
Cryobag, 14 x 28, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1428
In Commercial Distribution

  • 10816203020700 ()


  • Blood/tissue storage/culture container
Cryobag, 14 x 20, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1420
In Commercial Distribution

  • 10816203020687 ()
  • 00816203020680 ()


  • Blood/tissue storage/culture container
Cryobag, 10x16, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1016
In Commercial Distribution

  • 10816203020663 ()


  • Blood/tissue storage/culture container
Cryobag, 19 x 36, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1936
Not in Commercial Distribution

  • 10816203020694 ()


  • Blood/tissue storage/culture container
Cryobag, 09x15, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB0915
Not in Commercial Distribution

  • 10816203020656 ()


  • Blood/tissue storage/culture container
CryoStore 750 EVA Freezing Bag, 80-190ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS750KS
In Commercial Distribution

  • 20816203023746 ()
  • 10816203023749 ()
CS750KS

  • Blood/tissue storage/culture container
CryoStore 500 EVA Freezing Bag, 55 - 100ml "K" Tube Set, double aseptically packed.
ORIGEN BIOMEDICAL, INC.
CS500KS
In Commercial Distribution

  • 20816203023739 ()
  • 10816203023732 ()
CS500KS

  • Blood/tissue storage/culture container
CryoStore 50 EVA Freezing Bag,10-30ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS50KS
In Commercial Distribution

  • 20816203023722 ()
  • 10816203023725 ()
CS50KS

  • Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250S
In Commercial Distribution

  • 20816203023647 ()
  • 10816203023640 ()
CS250S

  • Blood/tissue storage/culture container
CryoStore multiple bag set, six 20 EVA freezing bags, 20-30ml, "V6" Tube Set
ORIGEN BIOMEDICAL, INC.
CS20V6
In Commercial Distribution

  • 20816203023586 ()
  • 10816203023589 ()
CS20V6

  • Blood/tissue storage/culture container
CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "NS" Tube Set
ORIGEN BIOMEDICAL, INC.
CS20NS
In Commercial Distribution

  • 20816203023579 ()
  • 10816203023572 ()
CS20NS

  • Blood/tissue storage/culture container
CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "F" Tube Set
ORIGEN BIOMEDICAL, INC.
CS20F
In Commercial Distribution

  • 20816203023562 ()
  • 10816203023565 ()
  • 00816203023568 ()
CS20F

  • Blood/tissue storage/culture container
CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS20N
In Commercial Distribution

  • 20816203023555 ()
  • 10816203023558 ()
  • 00816203023551 ()
CS20N

  • Blood/tissue storage/culture container
CryoStore 500 EVA Freezing Bag, 8-bag set, 55-100ml, "V8" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500V8
In Commercial Distribution

  • 20816203023159 ()
  • 10816203023152 ()


  • Blood/tissue storage/culture container
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
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F21" Tubing Set, with IBS and male luer cap, singly packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS250F21P
In Commercial Distribution

  • 20816203020714 ()
  • 10816203020717 ()


  • Blood/tissue storage/culture container
CryoBag with ports, 10ml Kapton and FEP bag
ORIGEN BIOMEDICAL, INC.
CB10K2
In Commercial Distribution

  • 10816203020472 ()


  • Blood/tissue storage/culture container
5 male luers with one 20cm SCD Tube and pinch clamp
ORIGEN BIOMEDICAL, INC.
CC35-5MT
In Commercial Distribution

  • 20816203023173 ()
  • 10816203023176 ()


  • Fluid transfer set, general-purpose
Two 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.
CC1
In Commercial Distribution

  • 20816203020059 ()
  • 10816203020052 ()


  • Intravenous fluid bag spike
One spike and male luer 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.
CC2
In Commercial Distribution

  • 20816203020066 ()
  • 10816203020069 ()


  • 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
Hemofiltration Tubing Set, singly aseptically pouched
ORIGEN BIOMEDICAL, INC.
HFT
In Commercial Distribution

  • 10816203021639 ()


  • Fluid transfer set, general-purpose
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
One female luer to 9 male luers, 45cm PVC tubing, with pinch clamps
ORIGEN BIOMEDICAL, INC.
45-F-9M
In Commercial Distribution

  • 20816203023197 ()
  • 10816203023190 ()
45-F-9M

  • 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
Two spikes to nine male luers with 140cm SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
2S-9M141
Not in Commercial Distribution

  • 20816203023265 ()
  • 10816203023268 ()


  • Fluid transfer set, general-purpose
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