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 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
PermaLife Cell Culture bag, 750ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL750T
In Commercial Distribution

  • 20816203023630 ()
  • 10816203023633 ()
PL750T

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL325T
In Commercial Distribution

  • 20816203023623 ()
  • 10816203023626 ()
PL325T

  • Blood/tissue storage/culture container
PermaLife Cell Culture bag, 240ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL240T
In Commercial Distribution

  • 20816203023616 ()
  • 10816203023619 ()
PL240T

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL120T
In Commercial Distribution

  • 20816203023609 ()
  • 10816203023602 ()
PL120T

  • Blood/tissue storage/culture container
PermaLife Cell Culture bag, 30ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL30T
In Commercial Distribution

  • 10816203023596 ()
  • 20816203023593 ()
PL30T

  • 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
Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamps.
ORIGEN BIOMEDICAL, INC.
40-PF-2M
In Commercial Distribution

  • 20816203023432 ()
  • 10816203023435 ()


  • Fluid transfer set, general-purpose
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
Two spikes to nine male luers with 140cm SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
2S-9M141
In Commercial Distribution

  • 20816203023265 ()
  • 10816203023268 ()


  • Fluid transfer set, general-purpose
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
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
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
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
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
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
Cell and Tissue Freezing bag, 19 x 50 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV1950
In Commercial Distribution

  • 10816203022810 ()


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 14 x 30 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV1430
In Commercial Distribution

  • 10816203022803 ()


  • Blood/tissue storage/culture container
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