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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Needle-free valve with caps, case of 10
ORIGEN BIOMEDICAL, INC.
NFV
In Commercial Distribution

  • 10816203020120 ()
  • 20816203020127 ()


  • Fluid transfer set, general-purpose
120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm in length
ORIGEN BIOMEDICAL, INC.
EV120 + F-M12
In Commercial Distribution

  • 10816203020090 ()
  • 20816203020097 ()


  • Blood/tissue storage/culture container
1000ml Cell Culture Bag, EVO film, "N" tube set, case of 12
ORIGEN BIOMEDICAL, INC.
EV1000N
In Commercial Distribution

  • 10816203020083 ()
  • 20816203020080 ()


  • Blood/tissue storage/culture container
One spike and male luer 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.
CC2
In Commercial Distribution

  • 20816203020066 ()
  • 10816203020069 ()


  • Intravenous fluid bag spike
DMSO resistant Bag Spike w/ Needle-Free Injection Port
ORIGEN BIOMEDICAL, INC.
CBS
In Commercial Distribution

  • 10816203020045 ()
  • 20816203020042 ()


  • Intravenous fluid bag spike
Two spikes to one spike port with 20cm SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
2S-P20
In Commercial Distribution

  • 10816203020021 ()
  • 20816203020028 ()


  • Intravenous fluid bag spike
One female luer with 15cm of SCD tubing, case of 50
ORIGEN BIOMEDICAL, INC.
15-F-T
In Commercial Distribution

  • 10816203020007 ()
  • 20816203020004 ()


  • Fluid transfer set, general-purpose
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, 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, 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, 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, 30 ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL30-2G
In Commercial Distribution

  • 10816203023336 ()
PL30-2G

  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 19 x 50 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV1950
In Commercial Distribution

  • 10816203022810 ()


  • Blood/tissue storage/culture container
Cell and Tissue Freezing bag, 9 x 18 cm Poche de Congélation Cellulaire et Tissue Zell- und Gewebe-Gefrierbeutel
ORIGEN BIOMEDICAL, INC.
TV0918
In Commercial Distribution

  • 10816203022797 ()


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

  • 00816203022615 ()
  • 10816203022612 ()


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

  • 00816203022608 ()
  • 10816203022605 ()


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

  • 00816203022592 ()
  • 10816203022599 ()


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

  • 00816203022585 ()
  • 10816203022582 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 4X19cm
ORIGEN BIOMEDICAL, INC.
OW0419
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
In Commercial Distribution

  • 10816203022469 ()
  • 20816203022466 ()


  • Fluid transfer set, general-purpose
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
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
PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
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
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
Cryostore 2000 EVA Freezing Bag, 4-bag Set, 180-450ml, "V8" Tubing Set, double aseptically pouched.
ORIGEN BIOMEDICAL, INC.
CS2000V8S
In Commercial Distribution

  • 20816203022299 ()
  • 10816203022292 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 24x36cm
ORIGEN BIOMEDICAL, INC.
OW2436
In Commercial Distribution

  • 00816203022257 ()
  • 10816203022254 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450ml, "Standard" Tube Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS2000
In Commercial Distribution

  • 10816203022230 ()
  • 20816203022237 ()
  • 00816203022233 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing,19x50cm
ORIGEN BIOMEDICAL, INC.
OW1950
In Commercial Distribution

  • 00816203022226 ()
  • 10816203022223 ()


  • Blood/tissue storage/culture container
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, 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, 16F
ORIGEN BIOMEDICAL, INC.
VV16F
In Commercial Distribution

  • 10816203022070 ()


  • 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
PermaLife Cell Culture Bag, 2000ml, "P2" Set, packed with additional NFV cover
ORIGEN BIOMEDICAL, INC.
PL2000P2
In Commercial Distribution

  • 10816203021776 ()


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

  • 10816203021646 ()
  • 20816203021643 ()


  • Intravenous fluid bag spike
Female to female luer adapter
ORIGEN BIOMEDICAL, INC.
F2F
In Commercial Distribution

  • 10816203021622 ()
  • 20816203021629 ()


  • Fluid transfer set, general-purpose
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 in OW
ORIGEN BIOMEDICAL, INC.
CS500SW
In Commercial Distribution

  • 10816203021233 ()
  • 20816203021230 ()


  • 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, 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 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, 55 - 100 ml, "F1" Tubing Set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS500F1S
In Commercial Distribution

  • 10816203021165 ()
  • 20816203021162 ()


  • Blood/tissue storage/culture container
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