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

  • 10816203021769 ()
  • 00816203021762 ()


  • Patient-washing mitten
60ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF60-T
In Commercial Distribution

  • 10816203020571 ()
  • 20816203020578 ()


  • Fluid transfer set, general-purpose
3ml BD syringe on a female luer with 15cm of SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R3FT
In Commercial Distribution

  • 10816203020564 ()
  • 20816203020561 ()


  • Fluid transfer set, general-purpose
CryoStore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS500NS
In Commercial Distribution

  • 10816203020373 ()
  • 20816203020370 ()
CS500NS

  • Blood/tissue storage/culture container
CryoStore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500N
In Commercial Distribution

  • 20816203020363 ()
  • 10816203020366 ()
  • 00816203020369 ()
CS500N

  • Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25N
In Commercial Distribution

  • 20816203020356 ()
  • 10816203020359 ()
  • 00816203020352 ()
CS25N

  • Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set, double aseptically packed in OW
ORIGEN BIOMEDICAL, INC.
CS250NSW
In Commercial Distribution

  • 10816203020335 ()
  • 20816203020332 ()
CS250NSW

  • Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "N" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS250NS
In Commercial Distribution

  • 10816203020328 ()
  • 20816203020325 ()
CS250NS

  • 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 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 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 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
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
CryoStore 750 EVA Freezing Bag, 80-190ml, "K" Tube Set, double aseptically packed
ORIGEN BIOMEDICAL, INC.
CS750KS
In Commercial Distribution

  • 20816203023746 ()
  • 10816203023749 ()
CS750KS

  • Blood/tissue storage/culture container
CryoStore 500 EVA Freezing Bag, 55 - 100ml "K" Tube Set, double aseptically packed.
ORIGEN BIOMEDICAL, INC.
CS500KS
In Commercial Distribution

  • 20816203023739 ()
  • 10816203023732 ()
CS500KS

  • Blood/tissue storage/culture container
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 tubing
ORIGEN BIOMEDICAL, INC.
PL750T
In Commercial Distribution

  • 20816203023630 ()
  • 10816203023633 ()
PL750T

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, with tubing
ORIGEN BIOMEDICAL, INC.
PL325T
In Commercial Distribution

  • 20816203023623 ()
  • 10816203023626 ()
PL325T

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 240ml, with tubing
ORIGEN BIOMEDICAL, INC.
PL240T
In Commercial Distribution

  • 20816203023616 ()
  • 10816203023619 ()
PL240T

  • Blood/tissue storage/culture container
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