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, 120ml, with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution

  • 10816203021769 ()
  • 00816203021762 ()


  • Patient-washing mitten
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
O-Wrap overwrap 3-layer pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430T
In Commercial Distribution

  • 00816203022202 ()
  • 10816203022209 ()


  • 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
Two 4-way stopcocks adhesive bonded
ORIGEN BIOMEDICAL, INC.
SC-2
In Commercial Distribution

  • 20816203022046 ()
  • 10816203022049 ()


  • Fluid transfer set, general-purpose
Spike extender set, resistant to 80% DMSO, case of 24
ORIGEN BIOMEDICAL, INC.
ST-A
In Commercial Distribution

  • 10816203021974 ()
  • 20816203021971 ()


  • Fluid transfer set, general-purpose
One spike with male to male luer, case of 50
ORIGEN BIOMEDICAL, INC.
SM
In Commercial Distribution

  • 10816203021967 ()
  • 20816203021964 ()


  • Fluid transfer set, general-purpose
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