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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Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50N
In Commercial Distribution

  • 20816203020417 ()
  • 10816203020410 ()
  • 00816203020413 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA 3-Bag set with spike, 55-100ml, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS500V3S
In Commercial Distribution

  • 10816203020403 ()
  • 20816203020400 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 12, singly packed in triple OW
ORIGEN BIOMEDICAL, INC.
CS500NSWT
In Commercial Distribution

  • 10816203020397 ()
  • 20816203020394 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" tube set, case of 12, double aseptic packed in OW
ORIGEN BIOMEDICAL, INC.
CS500NSW
In Commercial Distribution

  • 10816203020380 ()
  • 20816203020387 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, double aseptic pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS500NS
In Commercial Distribution

  • 10816203020373 ()
  • 20816203020370 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500N
In Commercial Distribution

  • 20816203020363 ()
  • 10816203020366 ()
  • 00816203020369 ()


  • Blood/tissue storage/culture container
Cryostore 25 EVA Freezing Bag, 10 - 25 ml, "N" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution

  • 20816203020356 ()
  • 10816203020359 ()
  • 00816203020352 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS250Y12S
In Commercial Distribution

  • 10816203020342 ()
  • 20816203020349 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" tube set, case of 12, double aseptic packed in OW
ORIGEN BIOMEDICAL, INC.
CS250NSW
In Commercial Distribution

  • 10816203020335 ()
  • 20816203020332 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS250NS
In Commercial Distribution

  • 10816203020328 ()
  • 20816203020325 ()


  • Blood/tissue storage/culture container
Cryostore 2000 EVA Freezing Bag, 180-450ml, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS2000aY8SW
In Commercial Distribution

  • 10816203020304 ()
  • 20816203020301 ()


  • Blood/tissue storage/culture container
Cryostore 1950 EVA Freezing Bag, "Y8" Tubing Set, double aseptically pouched in OW, case of 12
ORIGEN BIOMEDICAL, INC.
CS1950aY8SW
In Commercial Distribution

  • 10816203020298 ()
  • 20816203020295 ()


  • Blood/tissue storage/culture container
Vial spike with needle-free valve, pack of 10
ORIGEN BIOMEDICAL, INC.
VSV
In Commercial Distribution

  • 20816203020288 ()
  • 10816203020281 ()


  • Fluid transfer set, general-purpose
One spike to 1 male luer w/50cm SCD tubing & roller clamp
ORIGEN BIOMEDICAL, INC.
SU-M50
In Commercial Distribution

  • 10816203020274 ()
  • 20816203020271 ()


  • 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-M50
In Commercial Distribution

  • 20816203020264 ()
  • 10816203020267 ()


  • Fluid transfer set, general-purpose
One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-M10
In Commercial Distribution

  • 10816203020250 ()
  • 20816203020257 ()


  • Fluid transfer set, general-purpose
One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F50
In Commercial Distribution

  • 10816203020243 ()
  • 20816203020240 ()


  • Fluid transfer set, general-purpose
One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp, case of 50
ORIGEN BIOMEDICAL, INC.
S-F10
In Commercial Distribution

  • 10816203020236 ()
  • 20816203020233 ()


  • Fluid transfer set, general-purpose
6ml syringe on a needle-free valve with 15cm SCD tubing with porous vent plug , case of 25
ORIGEN BIOMEDICAL, INC.
RV-T15
In Commercial Distribution

  • 10816203020229 ()
  • 20816203020226 ()


  • Fluid transfer set, general-purpose
60ml syringe on a needle-free valve with 15cm SCD tubing with porous vent plug, case of 25
ORIGEN BIOMEDICAL, INC.
RV50-T15
In Commercial Distribution

  • 10816203020212 ()
  • 20816203020219 ()


  • Fluid transfer set, general-purpose
6ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
RF-T15
In Commercial Distribution

  • 10816203020205 ()
  • 20816203020202 ()


  • Fluid transfer set, general-purpose
3ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
R3F-T15
In Commercial Distribution

  • 10816203020199 ()
  • 20816203020196 ()


  • Fluid transfer set, general-purpose
PermaLife Cell Culture Bag, 70ml
ORIGEN BIOMEDICAL, INC.
PL70
In Commercial Distribution

  • 10816203020182 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml
ORIGEN BIOMEDICAL, INC.
PL325
In Commercial Distribution

  • 10816203020175 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml
ORIGEN BIOMEDICAL, INC.
PL30
In Commercial Distribution

  • 10816203020168 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 240ml
ORIGEN BIOMEDICAL, INC.
PL240
In Commercial Distribution

  • 10816203020151 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml
ORIGEN BIOMEDICAL, INC.
PL120
In Commercial Distribution

  • 10816203020144 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 7ml
ORIGEN BIOMEDICAL, INC.
PL07
In Commercial Distribution

  • 10816203020137 ()


  • Blood/tissue storage/culture container
Needle-free valve with caps, case of 10
ORIGEN BIOMEDICAL, INC.
NFV
In Commercial Distribution

  • 10816203020120 ()
  • 20816203020127 ()


  • Fluid transfer set, general-purpose
DMSO-Resistant Bag Spike with non- ahdered needle injection port, case of 50
ORIGEN BIOMEDICAL, INC.
IBS-X
In Commercial Distribution

  • 10816203020113 ()
  • 20816203020110 ()


  • Intravenous fluid bag spike
DMSO-Resistant Bag Spike with needle injection port, case of 50
ORIGEN BIOMEDICAL, INC.
IBS
In Commercial Distribution

  • 10816203020106 ()
  • 20816203020103 ()


  • Intravenous fluid bag spike
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
Two spikes 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.
CC1
In Commercial Distribution

  • 20816203020059 ()
  • 10816203020052 ()


  • 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
Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps
ORIGEN BIOMEDICAL, INC.
4S-4M60
In Commercial Distribution

  • 10816203020038 ()
  • 20816203020035 ()


  • 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
PermaLife Cell Culture Bag, 120ml, with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution

  • 10816203021769 ()
  • 00816203021762 ()


  • Patient-washing mitten
Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a spike port, and a CS25 for final freezing of product
ORIGEN BIOMEDICAL, INC.
10-200-CS25
Not in Commercial Distribution

  • 20816203023296 ()
  • 10816203023299 ()


  • Blood washing/centrifugation bag
Two 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port
ORIGEN BIOMEDICAL, INC.
10-200-2
Not in Commercial Distribution

  • 20816203023289 ()
  • 10816203023282 ()


  • Blood washing/centrifugation bag
One 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port
ORIGEN BIOMEDICAL, INC.
10-200
Not in Commercial Distribution

  • 20816203023272 ()
  • 10816203023275 ()
  • 00816203023278 ()


  • Blood washing/centrifugation bag
Two spikes to nine male luers with 140cm SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
2S-9M141
Not in Commercial Distribution

  • 20816203023265 ()
  • 10816203023268 ()


  • Fluid transfer set, general-purpose
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
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
Not in Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


  • Fluid transfer set, general-purpose
O-Wrap overwrap 3-layer pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430T
Not 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
Not in Commercial Distribution

  • 10816203022193 ()
  • 20816203022190 ()


  • Blood transfer set
Cryobag, 19 x 36, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1936
Not in Commercial Distribution

  • 10816203020694 ()


  • Blood/tissue storage/culture container
Cryobag, 09x15, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB0915
Not in Commercial Distribution

  • 10816203020656 ()


  • Blood/tissue storage/culture container
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