Company Name Brand Name GMDN Term FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Class Implantable

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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 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
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 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
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
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