Company Name Brand Name GMDN Term 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 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
Spike port to six male luers. Singly pouched, 12 per case.
ORIGEN BIOMEDICAL, INC.
30-P-6M
In Commercial Distribution

  • 20816203022435 ()
  • 10816203022438 ()


  • Intravenous fluid bag spike
PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
In Commercial Distribution

  • 10816203022377 ()


  • Blood/tissue storage/culture container
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
Evolve Tissue Culture Bag, 500-2000ml, "N" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
EV3000N
In Commercial Distribution

  • 20816203021865 ()
  • 10816203021868 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 750ml
ORIGEN BIOMEDICAL, INC.
PL750
In Commercial Distribution

  • 10816203021851 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 500ml, "P" Set, packed with additional PVC spike port
ORIGEN BIOMEDICAL, INC.
PL500P
In Commercial Distribution

  • 10816203021844 ()


  • Blood/tissue storage/culture container
325ml Cell Culture bag, FEP, 4th Generation
ORIGEN BIOMEDICAL, INC.
PL325-4G
In Commercial Distribution

  • 10816203021820 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml Flush Bag, "J" Set, assembled
ORIGEN BIOMEDICAL, INC.
PL30J
In Commercial Distribution

  • 10816203021806 ()


  • Blood/tissue storage/culture container
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
Cryostore 50 EVA 4- Bag Set, 10-30ml, "Standard" Tubing Set, 1 set per pouch, case of 6
ORIGEN BIOMEDICAL, INC.
CS50V4
In Commercial Distribution

  • 10816203021387 ()
  • 20816203021384 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS50SW
In Commercial Distribution

  • 10816203021363 ()
  • 20816203021360 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS50S
In Commercial Distribution

  • 10816203021349 ()
  • 20816203021346 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24, heat sealed
ORIGEN BIOMEDICAL, INC.
CS50H
In Commercial Distribution

  • 20816203021322 ()
  • 10816203021325 ()
  • 00816203021328 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10-30ml, "F15" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50F15
In Commercial Distribution

  • 20816203021278 ()
  • 10816203021271 ()
  • 00816203021274 ()


  • Blood/tissue storage/culture container
Custom 500ml EVA 2-bag set with spikes, 1 set per pouch, 12 sets per case
ORIGEN BIOMEDICAL, INC.
CS500V2P
In Commercial Distribution

  • 10816203021257 ()
  • 20816203021254 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
In Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml "M4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500M4
In Commercial Distribution

  • 20816203021216 ()
  • 10816203021219 ()
  • 00816203021212 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, custom length, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i3
In Commercial Distribution

  • 20816203021209 ()
  • 10816203021202 ()
  • 00816203021205 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2PW
In Commercial Distribution

  • 10816203021196 ()
  • 20816203021193 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2
In Commercial Distribution

  • 10816203021189 ()
  • 20816203021186 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i
In Commercial Distribution

  • 20816203021179 ()
  • 10816203021172 ()
  • 00816203021175 ()


  • 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
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
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
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
One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M50C
In Commercial Distribution

  • 10816203022469 ()
  • 20816203022466 ()


  • Fluid transfer set, general-purpose
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 ()


  • Fluid transfer set, general-purpose
One spike to one female luer with 12cm SCD Tubing, case of 50
ORIGEN BIOMEDICAL, INC.
F-S12
In Commercial Distribution

  • 10816203022339 ()
  • 20816203022336 ()


  • Fluid transfer set, general-purpose
One female luer to one male luer with 12cm DMSO resistant tubing, singly aseptically pouched, case of 50
ORIGEN BIOMEDICAL, INC.
F-M12
In Commercial Distribution

  • 10816203022322 ()
  • 20816203022329 ()


  • Fluid transfer set, general-purpose
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
In Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


  • Fluid transfer set, general-purpose
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
One spike, vented drip chamber to 9 male luers w/140cm SCD tubing, pinch clamps
ORIGEN BIOMEDICAL, INC.
SDv-9M141
In Commercial Distribution

  • 10816203021950 ()
  • 20816203021957 ()


  • Fluid transfer set, general-purpose
4-way stopcock, individually pouched, case of 50
ORIGEN BIOMEDICAL, INC.
SC-1
In Commercial Distribution

  • 10816203021943 ()
  • 20816203021940 ()


  • Fluid transfer set, general-purpose
One spike to one spike with 50cm of SCD tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-S50
In Commercial Distribution

  • 10816203021936 ()
  • 20816203021933 ()


  • Fluid transfer set, general-purpose
One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F15
In Commercial Distribution

  • 10816203021929 ()
  • 20816203021926 ()


  • Fluid transfer set, general-purpose
One spike to one 3/8" barb with 12cm DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
S-38B12
In Commercial Distribution

  • 10816203021912 ()
  • 20816203021919 ()


  • Fluid transfer set, general-purpose
One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps, case of 20
ORIGEN BIOMEDICAL, INC.
S-FFP12
In Commercial Distribution

  • 10816203021905 ()
  • 20816203021902 ()


  • Fluid transfer set, general-purpose
60ml syringe with a cap, double aseptic pouched 20 to a case
ORIGEN BIOMEDICAL, INC.
R60-CS
In Commercial Distribution

  • 10816203021899 ()
  • 20816203021896 ()


  • Fluid transfer set, general-purpose
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