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 250 EVA Freezing Bag, 30-70ml, K Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250KS
In Commercial Distribution

  • 20816203023753 ()
  • 10816203023756 ()
CS250KS

  • 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
PermaLife Cell Culture Bag, 2000ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL2000K
In Commercial Distribution

  • 10816203023718 ()
PL2000K

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 1000ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL1000K
In Commercial Distribution

  • 10816203023701 ()
PL1000K

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 750ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL750K
In Commercial Distribution

  • 10816203023695 ()
PL750K

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 500ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL500K
In Commercial Distribution

  • 10816203023688 ()
PL500K

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL120K
In Commercial Distribution

  • 10816203023671 ()
PL120K

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 70ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL70K
In Commercial Distribution

  • 10816203023664 ()
PL70K

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL30K
In Commercial Distribution

  • 10816203023657 ()
PL30K

  • 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 tubing
ORIGEN BIOMEDICAL, INC.
PL750T
In Commercial Distribution

  • 20816203023630 ()
  • 10816203023633 ()
PL750T

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

  • 20816203023623 ()
  • 10816203023626 ()
PL325T

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

  • 20816203023616 ()
  • 10816203023619 ()
PL240T

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

  • 20816203023609 ()
  • 10816203023602 ()
PL120T

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

  • 10816203023596 ()
  • 20816203023593 ()
PL30T

  • Blood/tissue storage/culture container
CryoStore 20 FLEX EVA Freezing Bag, 20-30ml, “V” Tube Set
ORIGEN BIOMEDICAL, INC.
CS20V6
In Commercial Distribution

  • 20816203023586 ()
  • 10816203023589 ()
CS20V6

  • Blood/tissue storage/culture container
CryoStore 20 FLEX EVA Freezing Bag, 20-30ml, “N” Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS20NS
In Commercial Distribution

  • 20816203023579 ()
  • 10816203023572 ()
CS20NS

  • Blood/tissue storage/culture container
CryoStore 20 FLEX EVA 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
6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R6F-TA
In Commercial Distribution

  • 20816203023449 ()
  • 10816203023442 ()
15-R6F-TA

  • Blood transfer set
Cryostore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, singly packed
ORIGEN BIOMEDICAL, INC.
CS500NP
Not 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 ()
PL2000P2-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 1000ml, "P" Set, packed with additional spike port - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL1000P-2G
In Commercial Distribution

  • 10816203023404 ()
PL1000P-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 750 mL - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL750-2G
In Commercial Distribution

  • 10816203023398 ()
PL750-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 500 mL, "P" Set, packed with additional PVC spike port - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL500P-2G
In Commercial Distribution

  • 10816203023381 ()
PL500P-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325 mL - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL325-2G
In Commercial Distribution

  • 10816203023374 ()
PL325-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 240 mL - 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
PermaLife Cell Culture Bag, 7 mL - 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
Not in Commercial Distribution

  • 20816203023319 ()
  • 10816203023312 ()
CC3

  • Blood transfer set
CryoStore 50 EVA Freezing Bag, 7-Bag Set, 10-30ml, "V9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50V9
Not 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
Not 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
Not 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
Not 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
Not in Commercial Distribution

  • 20816203023265 ()
  • 10816203023268 ()


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

  • 10816203023251 ()
PL750N

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

  • 10816203023244 ()
PL120N

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

  • 10816203023237 ()
PL325N

  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 4-bag Set, 10-30ml, "V8" tubing set
ORIGEN BIOMEDICAL, INC.
CS50V8S
Not 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
Not 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
Not 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
Not 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 ()
PL325M

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, "L" Set with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325L
Not in Commercial Distribution

  • 10816203022995 ()


  • Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250N
In Commercial Distribution

  • 10816203022889 ()
  • 00816203022882 ()
  • 20816203022886 ()
CS250N

  • 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
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