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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O-Wrap, overwrap pouch for freezing,19x50cm
ORIGEN BIOMEDICAL, INC.
OW1950
In Commercial Distribution

  • 00816203022226 ()
  • 10816203022223 ()


  • Blood/tissue storage/culture container
O-Wrap overwrap 3-layer pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430T
Not in Commercial Distribution

  • 00816203022202 ()
  • 10816203022209 ()


  • 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 w/ Needle-Free Injection Port
ORIGEN BIOMEDICAL, INC.
CBS
In Commercial Distribution

  • 10816203020045 ()
  • 20816203020042 ()


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

  • 10816203021646 ()
  • 20816203021643 ()


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

  • 10816203021622 ()
  • 20816203021629 ()


  • Fluid transfer set, general-purpose
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
Evolve Tissue Culture Bag, 120ml, case of 20
ORIGEN BIOMEDICAL, INC.
EV120
In Commercial Distribution

  • 10816203021592 ()
  • 20816203021599 ()


  • Blood/tissue storage/culture container
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
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250N
In Commercial Distribution

  • 10816203022889 ()
  • 00816203022882 ()
  • 20816203022886 ()


  • Blood/tissue storage/culture container
Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS750Y12S
In Commercial Distribution

  • 10816203020526 ()
  • 20816203020523 ()


  • Blood/tissue storage/culture container
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
CryoStore 50 EVA Freezing Bag, 7-Bag Set, 10-30ml, "V9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50V9
In Commercial Distribution

  • 20816203023302 ()
  • 10816203023305 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 4-bag Set, 10-30ml, "V8" tubing set
ORIGEN BIOMEDICAL, INC.
CS50V8S
In Commercial Distribution

  • 10816203023169 ()
  • 20816203023166 ()


  • 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
In Commercial Distribution

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


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1A
In Commercial Distribution

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


  • 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
Cryostore 2500 Conical EVA Freezing Bag, 730-810ml, " Y14" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CSD2500Y14
In Commercial Distribution

  • 10816203021547 ()
  • 20816203021544 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750
In Commercial Distribution

  • 20816203021537 ()
  • 10816203021530 ()
  • 00816203021533 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y11" Tubing Set, case of 50
ORIGEN BIOMEDICAL, INC.
CS750Y11
In Commercial Distribution

  • 20816203021520 ()
  • 10816203021523 ()
  • 00816203021526 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750Y10
In Commercial Distribution

  • 20816203021513 ()
  • 10816203021516 ()
  • 00816203021519 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA 3-Bag set with drip spikes, 80-190ml, case of 6 sets
ORIGEN BIOMEDICAL, INC.
CS750V4
In Commercial Distribution

  • 10816203021509 ()
  • 20816203021506 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3
In Commercial Distribution

  • 10816203021493 ()
  • 20816203021490 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double pouched
ORIGEN BIOMEDICAL, INC.
CS750M2S
In Commercial Distribution

  • 10816203021455 ()
  • 20816203021452 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F8" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F8
In Commercial Distribution

  • 20816203021445 ()
  • 10816203021448 ()
  • 00816203021441 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 20
ORIGEN BIOMEDICAL, INC.
CS750F5-2
In Commercial Distribution

  • 20816203021438 ()
  • 10816203021431 ()
  • 00816203021434 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F5
In Commercial Distribution

  • 20816203021421 ()
  • 10816203021424 ()
  • 00816203021427 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, F1 tube set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS750F1S
In Commercial Distribution

  • 10816203021417 ()
  • 20816203021414 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "Y3" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50Y3
In Commercial Distribution

  • 20816203021407 ()
  • 10816203021400 ()
  • 00816203021403 ()


  • 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
Custom 50 EVA 2-Bag set with spikes, 10-30ml, 1 set per pouch, case of 12
ORIGEN BIOMEDICAL, INC.
CS50V2
In Commercial Distribution

  • 10816203021370 ()
  • 20816203021377 ()


  • 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, triply packed
ORIGEN BIOMEDICAL, INC.
CS50S-3
In Commercial Distribution

  • 10816203021356 ()
  • 20816203021353 ()


  • 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, M3 tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution

  • 20816203021339 ()
  • 10816203021332 ()
  • 00816203021335 ()


  • 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, "F4" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS50F4S
In Commercial Distribution

  • 10816203021318 ()
  • 20816203021315 ()


  • 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
Cryostore 500 EVA 3-Bag set with spikes, 55-100ml, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS500V3
In Commercial Distribution

  • 10816203021264 ()
  • 20816203021261 ()


  • 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
Custom 500ml EVA 2-bag set with spikes, 2 sets per Tyvek pouch, 12 sets per case
ORIGEN BIOMEDICAL, INC.
CS500V2
In Commercial Distribution

  • 20816203021247 ()
  • 10816203021240 ()
  • 00816203021243 ()


  • 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
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