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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PermaLife Cell Culture Bag, 1000ml, "P" Set, packed with additional spike port
ORIGEN BIOMEDICAL, INC.
PL1000P
In Commercial Distribution

  • 10816203021752 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 7ml, "J" Set
ORIGEN BIOMEDICAL, INC.
PL07J
In Commercial Distribution

  • 10816203021745 ()


  • Blood/tissue storage/culture container
Percutaneous Introducer Kit, singly aspetically pouched
ORIGEN BIOMEDICAL, INC.
PCTa
In Commercial Distribution

  • 10816203021721 ()


  • Vascular catheter introduction set, nonimplantable
Protective Cap for female luer, case of 50
ORIGEN BIOMEDICAL, INC.
PC2-B
In Commercial Distribution

  • 20816203021704 ()
  • 10816203021707 ()


  • Fluid transfer set, general-purpose
DMSO-Resistant Bag Spike with needle injection port , bulk packed
ORIGEN BIOMEDICAL, INC.
IBS-B
In Commercial Distribution

  • 10816203021646 ()
  • 20816203021643 ()


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

  • 10816203021639 ()


  • Fluid transfer set, general-purpose
Female to female luer adapter
ORIGEN BIOMEDICAL, INC.
F2F
In Commercial Distribution

  • 10816203021622 ()
  • 20816203021629 ()


  • Fluid transfer set, general-purpose
One female luer to eight spikes with 100cm of SCD tubing and pinch clamps, case of 20
ORIGEN BIOMEDICAL, INC.
F-8S100
In Commercial Distribution

  • 10816203021615 ()
  • 20816203021612 ()


  • Intravenous fluid bag spike
Evolve Tissue Culture Bag, 120ml, case of 20
ORIGEN BIOMEDICAL, INC.
EV120
In Commercial Distribution

  • 10816203021592 ()
  • 20816203021599 ()


  • Blood/tissue storage/culture container
Cryostore 2500 Conical EVA Freezing Bag, 730-810ml, " Y14" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CSD2500Y14
In Commercial Distribution

  • 10816203021547 ()
  • 20816203021544 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750
In Commercial Distribution

  • 20816203021537 ()
  • 10816203021530 ()
  • 00816203021533 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y11" Tubing Set, case of 50
ORIGEN BIOMEDICAL, INC.
CS750Y11
In Commercial Distribution

  • 20816203021520 ()
  • 10816203021523 ()
  • 00816203021526 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750Y10
In Commercial Distribution

  • 20816203021513 ()
  • 10816203021516 ()
  • 00816203021519 ()


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 19 x 36 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV1936
In Commercial Distribution

  • 10816203021462 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F8" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F8
In Commercial Distribution

  • 20816203021445 ()
  • 10816203021448 ()
  • 00816203021441 ()


  • 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
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
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