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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Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes
ORIGEN BIOMEDICAL, INC.
PCT
In Commercial Distribution

  • 10816203023145 ()


  • Vascular catheter introduction set, nonimplantable
20ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF20-T
In Commercial Distribution

  • 20816203023050 ()
  • 10816203023053 ()


  • Fluid transfer set, general-purpose
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
In Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


  • Fluid transfer set, general-purpose
Adapter tube set, 4 bag spikes x 1 Male luer, 40cm
ORIGEN BIOMEDICAL, INC.
4S-M40
In Commercial Distribution

  • 10816203022193 ()
  • 20816203022190 ()


  • Intravenous fluid bag spike
RBC tube set, sealed tube with spike, FLL, and spike port
ORIGEN BIOMEDICAL, INC.
30-T-SPF
In Commercial Distribution

  • 20816203022183 ()
  • 10816203022186 ()


  • Intravenous fluid bag spike
PermaLife Cell Culture Bag, 750ml
ORIGEN BIOMEDICAL, INC.
PL750
In Commercial Distribution

  • 10816203021851 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, "K" set
ORIGEN BIOMEDICAL, INC.
PL325K
In Commercial Distribution

  • 10816203021837 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL30M
In Commercial Distribution

  • 10816203021813 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml Flush Bag, "J" Set, assembled
ORIGEN BIOMEDICAL, INC.
PL30J
In Commercial Distribution

  • 10816203021806 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 2000ml, "P" Set, packed with additional spike port
ORIGEN BIOMEDICAL, INC.
PL2000P
In Commercial Distribution

  • 10816203021783 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 2000ml, "P2" Set, packed with additional NFV cover
ORIGEN BIOMEDICAL, INC.
PL2000P2
In Commercial Distribution

  • 10816203021776 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 7ml, "J" Set
ORIGEN BIOMEDICAL, INC.
PL07J
In Commercial Distribution

  • 10816203021745 ()


  • Blood/tissue storage/culture container
Protective Cap for female luer, case of 50
ORIGEN BIOMEDICAL, INC.
PC2-B
In Commercial Distribution

  • 20816203021704 ()
  • 10816203021707 ()


  • Fluid transfer set, general-purpose
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, 10-30ml, "F4" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS50F4S
In Commercial Distribution

  • 10816203021318 ()
  • 20816203021315 ()


  • Blood/tissue storage/culture container
Cryostore 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
Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
In Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, 55 - 100 ml "M4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500M4
In Commercial Distribution

  • 20816203021216 ()
  • 10816203021219 ()
  • 00816203021212 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, custom length, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i3
In Commercial Distribution

  • 20816203021209 ()
  • 10816203021202 ()
  • 00816203021205 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2PW
In Commercial Distribution

  • 10816203021196 ()
  • 20816203021193 ()


  • Blood/tissue storage/culture container
Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i
In Commercial Distribution

  • 20816203021179 ()
  • 10816203021172 ()
  • 00816203021175 ()


  • Blood/tissue storage/culture container
Cryostore 400ml EVA Freezing Bag with standard tube set, 24 per case
ORIGEN BIOMEDICAL, INC.
CS400
In Commercial Distribution

  • 20816203021117 ()
  • 10816203021110 ()
  • 00816203021113 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing bag, 30-70ml with F7 Tube Set
ORIGEN BIOMEDICAL, INC.
CS250F7P
In Commercial Distribution

  • 10816203020915 ()
  • 20816203020912 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F5" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F5
In Commercial Distribution

  • 20816203020899 ()
  • 10816203020892 ()
  • 00816203020895 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F4
In Commercial Distribution

  • 20816203020875 ()
  • 10816203020878 ()
  • 00816203020871 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 250ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1
In Commercial Distribution

  • 20816203020844 ()
  • 10816203020847 ()
  • 00816203020840 ()


  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30-70ml, "F" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F
In Commercial Distribution

  • 20816203020837 ()
  • 10816203020830 ()
  • 00816203020833 ()


  • Blood/tissue storage/culture container
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