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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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
One 0.2um filter to sealed SCD tubing, sterile
ORIGEN BIOMEDICAL, INC.
15-T-FA
Not in Commercial Distribution

  • 20816203023067 ()
  • 10816203023060 ()


  • Blood transfer set
20ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF20-T
In Commercial Distribution

  • 20816203023050 ()
  • 10816203023053 ()


  • Blood transfer set
12ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF12-T
In Commercial Distribution

  • 20816203023043 ()
  • 10816203023046 ()


  • Blood transfer set
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
Cryostore 28 EVA Freezing Bag, 5-20 ml, F tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS28F
Not in Commercial Distribution

  • 10816203022841 ()
  • 20816203022848 ()
  • 00816203022844 ()


  • Blood/tissue storage/culture container
One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched
ORIGEN BIOMEDICAL, INC.
80HAS
In Commercial Distribution

  • 20816203022824 ()
  • 10816203022827 ()
80HAS

  • Blood transfer set
TissueVault, Cell and Tissue Freezing 19x50cm bag
ORIGEN BIOMEDICAL, INC.
TV1950
In Commercial Distribution

  • 10816203022810 ()
TV1950

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 14x30cm bag
ORIGEN BIOMEDICAL, INC.
TV1430
In Commercial Distribution

  • 10816203022803 ()
TV1430

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 9x18cm bag
ORIGEN BIOMEDICAL, INC.
TV0918
In Commercial Distribution

  • 10816203022797 ()
TV0918

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 9x9cm bag
ORIGEN BIOMEDICAL, INC.
TV0909
In Commercial Distribution

  • 10816203022780 ()
TV0909

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing,19x36cm
ORIGEN BIOMEDICAL, INC.
OW1936
In Commercial Distribution

  • 00816203022615 ()
  • 10816203022612 ()
OW1936

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430
In Commercial Distribution

  • 00816203022608 ()
  • 10816203022605 ()
OW1430

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x18cm
ORIGEN BIOMEDICAL, INC.
OW0918
In Commercial Distribution

  • 00816203022592 ()
  • 10816203022599 ()
OW0918

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x9cm.
ORIGEN BIOMEDICAL, INC.
OW0909
In Commercial Distribution

  • 00816203022585 ()
  • 10816203022582 ()
OW0909

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 4X19cm
ORIGEN BIOMEDICAL, INC.
OW0419
Not in Commercial Distribution

  • 10816203022575 ()
  • 00816203022578 ()


  • Blood/tissue storage/culture container
One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50C
Not in Commercial Distribution

  • 10816203022469 ()
  • 20816203022466 ()


  • Blood transfer set
Spike port to six male luers. Singly pouched, 12 per case.
ORIGEN BIOMEDICAL, INC.
30-P-6M
Not in Commercial Distribution

  • 20816203022435 ()
  • 10816203022438 ()


  • Blood transfer set
One spike to one spike with 10cm of SCD tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-S10
In Commercial Distribution

  • 10816203022384 ()
  • 20816203022381 ()


  • Blood transfer set
PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
Not in Commercial Distribution

  • 10816203022377 ()


  • Blood/tissue storage/culture container
One spike to one female luer with 12cm SCD Tubing, case of 50
ORIGEN BIOMEDICAL, INC.
F-S12
Not in Commercial Distribution

  • 10816203022339 ()
  • 20816203022336 ()


  • Blood transfer set
One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptically pouched, case of 50
ORIGEN BIOMEDICAL, INC.
F-M12
Not in Commercial Distribution

  • 10816203022322 ()
  • 20816203022329 ()


  • Blood transfer set
Cryostore 2000 EVA Freezing Bag, 4-bag Set, 180-450ml, "V8" Tubing Set, double aseptically pouched.
ORIGEN BIOMEDICAL, INC.
CS2000V8S
Not in Commercial Distribution

  • 20816203022299 ()
  • 10816203022292 ()


  • Blood/tissue storage/culture container
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
Not in Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


  • Blood transfer set
O-Wrap, overwrap pouch for freezing, 24x36cm
ORIGEN BIOMEDICAL, INC.
OW2436
In Commercial Distribution

  • 00816203022257 ()
  • 10816203022254 ()
OW2436

  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1A
Not in Commercial Distribution

  • 20816203022244 ()
  • 10816203022247 ()
  • 00816203022240 ()


  • Blood/tissue storage/culture container
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