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 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 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
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
PermaLife Cell Culture Bag, 7ml
ORIGEN BIOMEDICAL, INC.
PL07
In Commercial Distribution

  • 10816203020137 ()


  • Blood/tissue storage/culture container
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
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
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 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
Two male luers to one male luer with 17cm of DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
2M-M17
Not in Commercial Distribution

  • 10816203020601 ()
  • 20816203020608 ()


  • Fluid transfer set, general-purpose
One spike to one male luer with 150cm tubing and roller clamp
ORIGEN BIOMEDICAL, INC.
150-S-M
Not in Commercial Distribution

  • 10816203020588 ()
  • 20816203020585 ()


  • Fluid transfer set, general-purpose
One female luer to one male luer with 12cm DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
12-F-M
Not in Commercial Distribution

  • 10816203020557 ()
  • 20816203020554 ()


  • Fluid transfer set, general-purpose
4x12cm SCD tubing tube set
ORIGEN BIOMEDICAL, INC.
24-T-3T
Not in Commercial Distribution

  • 10816203020014 ()
  • 20816203020011 ()


  • Fluid transfer set, general-purpose
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