Company Name Brand Name GMDN Term 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, 55-100ml, "N" Tube Set, singly packed
ORIGEN BIOMEDICAL, INC.
CS500NP
In Commercial Distribution

  • 20816203023425 ()
  • 10816203023428 ()
CS500NP

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 2000ml, "P2" Set, packed with additional NFV cover
ORIGEN BIOMEDICAL, INC.
PL2000P2-2G
In Commercial Distribution

  • 10816203023411 ()


  • Blood/tissue storage/culture container
PermaLife cell culture bag, 1000ml, no green vent caps, "P" set, packed with additional spike port
ORIGEN BIOMEDICAL, INC.
PL1000P-2G
In Commercial Distribution

  • 10816203023404 ()
PL1000P-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 750ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL750-2G
In Commercial Distribution

  • 10816203023398 ()
PL750-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 500ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL500P-2G
In Commercial Distribution

  • 10816203023381 ()
PL500P-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 325ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL325-2G
In Commercial Distribution

  • 10816203023374 ()
PL325-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 240ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL240-2G
In Commercial Distribution

  • 10816203023367 ()
PL240-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 120ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL120-2G
In Commercial Distribution

  • 10816203023350 ()
PL120-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 70 ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL70-2G
In Commercial Distribution

  • 10816203023343 ()
PL70-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 30 ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL30-2G
In Commercial Distribution

  • 10816203023336 ()
PL30-2G

  • Blood/tissue storage/culture container
Cell culture bag, 7ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL07-2G
In Commercial Distribution

  • 10816203023329 ()
PL07-2G

  • Blood/tissue storage/culture container
Four 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.
CC3
In Commercial Distribution

  • 20816203023319 ()
  • 10816203023312 ()
CC3

  • Intravenous fluid bag spike
CryoStore 50 EVA Freezing Bag, 7-Bag Set, 10-30ml, "V9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50V9
In Commercial Distribution

  • 20816203023302 ()
  • 10816203023305 ()


  • Blood/tissue storage/culture container
Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a spike port, and a CS25 for final freezing of product
ORIGEN BIOMEDICAL, INC.
10-200-CS25
In Commercial Distribution

  • 20816203023296 ()
  • 10816203023299 ()


  • Blood washing/centrifugation bag
Two 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port
ORIGEN BIOMEDICAL, INC.
10-200-2
In Commercial Distribution

  • 20816203023289 ()
  • 10816203023282 ()


  • Blood washing/centrifugation bag
One 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port
ORIGEN BIOMEDICAL, INC.
10-200
In Commercial Distribution

  • 20816203023272 ()
  • 10816203023275 ()
  • 00816203023278 ()


  • Blood washing/centrifugation bag
PermaLife Cell Culture bag, 750ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL750N
In Commercial Distribution

  • 10816203023251 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL120N
In Commercial Distribution

  • 10816203023244 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL325N
In Commercial Distribution

  • 10816203023237 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 4-bag Set, 10-30ml, "V8" tubing set
ORIGEN BIOMEDICAL, INC.
CS50V8S
In Commercial Distribution

  • 10816203023169 ()
  • 20816203023166 ()


  • 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
Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes
ORIGEN BIOMEDICAL, INC.
PCT
In Commercial Distribution

  • 10816203023145 ()


  • Vascular catheter introduction set, nonimplantable
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
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
PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
In Commercial Distribution

  • 10816203022377 ()


  • 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, "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
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
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
PermaLife Cell Culture Bag, 500ml, "P" Set, packed with additional PVC spike port
ORIGEN BIOMEDICAL, INC.
PL500P
In Commercial Distribution

  • 10816203021844 ()


  • 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
325ml Cell Culture bag, FEP, 4th Generation
ORIGEN BIOMEDICAL, INC.
PL325-4G
In Commercial Distribution

  • 10816203021820 ()


  • 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, 30ml Flush Bag, "J" Set, assembled
ORIGEN BIOMEDICAL, INC.
PL30J
In Commercial Distribution

  • 10816203021806 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 240ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL240K
In Commercial Distribution

  • 10816203021790 ()


  • 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
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