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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ARCOS CON POSTES TAPERED 019*025 34MM Arcos en acero inox, origen EEUU
Acme Monaco Corporation
AMC192534MMUOF1TST
In Commercial Distribution

  • D972AMC192534MMUOF1TST0 ()
  • D972AMC192534MMUOF1TST2 ()


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

  • 10816203021769 ()
  • 00816203021762 ()


  • Blood/tissue storage/culture container
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
PermaLife Cell Culture bag, 750ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL750N
In Commercial Distribution

  • 10816203023251 ()
PL750N

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL325N
In Commercial Distribution

  • 10816203023237 ()
PL325N

  • Blood/tissue storage/culture container
5 male luers with one 20cm SCD Tube and pinch clamp
ORIGEN BIOMEDICAL, INC.
CC35-5MT
Not in Commercial Distribution

  • 20816203023173 ()
  • 10816203023176 ()


  • Blood transfer set
CryoStore 500 EVA Freezing Bag, 8-bag set, 55-100ml, "V8" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500V8
Not in Commercial Distribution

  • 20816203023159 ()
  • 10816203023152 ()


  • Blood/tissue storage/culture container
One 0.2um filter to sealed SCD tubing, sterile
ORIGEN BIOMEDICAL, INC.
15-T-FA
Not in Commercial Distribution

  • 20816203023067 ()
  • 10816203023060 ()


  • Blood transfer set
12ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF12-T
In Commercial Distribution

  • 20816203023043 ()
  • 10816203023046 ()


  • Blood transfer set
PermaLife Cell Culture Bag, 325ml with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325M
In Commercial Distribution

  • 10816203023008 ()
PL325M

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml, "L" Set with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325L
Not in Commercial Distribution

  • 10816203022995 ()


  • 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
TissueVault, Cell and Tissue Freezing 19x50cm bag
ORIGEN BIOMEDICAL, INC.
TV1950
In Commercial Distribution

  • 10816203022810 ()
TV1950

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 9x18cm bag
ORIGEN BIOMEDICAL, INC.
TV0918
In Commercial Distribution

  • 10816203022797 ()
TV0918

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430
In Commercial Distribution

  • 00816203022608 ()
  • 10816203022605 ()
OW1430

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x9cm.
ORIGEN BIOMEDICAL, INC.
OW0909
In Commercial Distribution

  • 00816203022585 ()
  • 10816203022582 ()
OW0909

  • Blood/tissue storage/culture container
Spike port to six male luers. Singly pouched, 12 per case.
ORIGEN BIOMEDICAL, INC.
30-P-6M
Not in Commercial Distribution

  • 20816203022435 ()
  • 10816203022438 ()


  • Blood transfer set
PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
Not in Commercial Distribution

  • 10816203022377 ()


  • 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
Not in Commercial Distribution

  • 10816203022322 ()
  • 20816203022329 ()


  • Blood transfer set
30ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R30F-T
Not in Commercial Distribution

  • 20816203022268 ()
  • 10816203022261 ()


  • Blood transfer set
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS250F1A
Not in Commercial Distribution

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


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing,19x50cm
ORIGEN BIOMEDICAL, INC.
OW1950
In Commercial Distribution

  • 00816203022226 ()
  • 10816203022223 ()
OW1950

  • 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
ECMO Reinforced Dual Lumen Cannula, 32F
ORIGEN BIOMEDICAL, INC.
VV32F
Not in Commercial Distribution

  • 10816203022148 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 23F
ORIGEN BIOMEDICAL, INC.
VV23F
Not in Commercial Distribution

  • 10816203022100 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 19F
ORIGEN BIOMEDICAL, INC.
VV19F
Not in Commercial Distribution

  • 10816203022094 ()


  • Mobile extracorporeal gas exchange system catheter kit
ECMO Reinforced Dual Lumen Cannula, 16F
ORIGEN BIOMEDICAL, INC.
VV16F
Not in Commercial Distribution

  • 10816203022070 ()


  • Mobile extracorporeal gas exchange system catheter kit
Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
Not in Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container
Cryostore 1000 EVA Freezing Bag, 120-275ml, "N" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS1000NS
Not in Commercial Distribution

  • 10816203020731 ()
  • 20816203020738 ()


  • Blood/tissue storage/culture container
CryoStore 1000 EVA Freezing Bag, 120 - 275 ml, "N" Tubing Set
ORIGEN BIOMEDICAL, INC.
CS1000N
In Commercial Distribution

  • 20816203020721 ()
  • 10816203020724 ()
  • 00816203020727 ()
CS1000N

  • Blood/tissue storage/culture container
Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F21" Tubing Set, with IBS and male luer cap, singly packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS250F21P
Not in Commercial Distribution

  • 20816203020714 ()
  • 10816203020717 ()


  • Blood/tissue storage/culture container
Cryobag, 14 x 28, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1428
Not in Commercial Distribution

  • 10816203020700 ()


  • Blood/tissue storage/culture container
Cryobag, 19 x 36, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1936
Not in Commercial Distribution

  • 10816203020694 ()


  • Blood/tissue storage/culture container
Cryobag, 14 x 20, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1420
Not in Commercial Distribution

  • 10816203020687 ()
  • 00816203020680 ()


  • Blood/tissue storage/culture container
Cryobag, 10x16, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB1016
Not in Commercial Distribution

  • 10816203020663 ()


  • Blood/tissue storage/culture container
Cryobag, 09x15, Kapton/FEP
ORIGEN BIOMEDICAL, INC.
CB0915
Not in Commercial Distribution

  • 10816203020656 ()


  • Blood/tissue storage/culture container
One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller clamps
ORIGEN BIOMEDICAL, INC.
40-S-V-SMM
Not in Commercial Distribution

  • 10816203020632 ()
  • 20816203020639 ()


  • Blood transfer set
Three spikes to sealed tubing with 100cm of SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
3S-T100
Not in Commercial Distribution

  • 10816203020625 ()
  • 20816203020622 ()


  • Blood transfer set
Two spike ports to one spike with 16cm SCD tubing
ORIGEN BIOMEDICAL, INC.
2P-S16
In Commercial Distribution

  • 20816203020615 ()
  • 10816203020618 ()


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

  • 10816203020601 ()
  • 20816203020608 ()


  • Blood transfer set
Two male luers to one female luer with 17cm of DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
2M-F17
Not in Commercial Distribution

  • 10816203020595 ()
  • 20816203020592 ()


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

  • 10816203020588 ()
  • 20816203020585 ()


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

  • 10816203020571 ()
  • 20816203020578 ()


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

  • 10816203020564 ()
  • 20816203020561 ()


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

  • 10816203020557 ()
  • 20816203020554 ()


  • Blood transfer set
Cryostore Harvest Kit, 750 EVA Freezing Bag, "Y12" Tubing Set, case of 12, double packed
ORIGEN BIOMEDICAL, INC.
CS750Y12S
Not in Commercial Distribution

  • 10816203020526 ()
  • 20816203020523 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, double aseptically pouched, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3S
Not in Commercial Distribution

  • 10816203020519 ()
  • 20816203020516 ()


  • Blood/tissue storage/culture container
Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 12, singly packed in triple O-Wrap
ORIGEN BIOMEDICAL, INC.
CS750NSWT
Not in Commercial Distribution

  • 10816203020502 ()
  • 20816203020509 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, double aseptic packed with OW
ORIGEN BIOMEDICAL, INC.
CS50NSW
Not in Commercial Distribution

  • 10816203020434 ()
  • 20816203020431 ()


  • Blood/tissue storage/culture container
Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "N" tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS50NS
In Commercial Distribution

  • 10816203020427 ()
  • 20816203020424 ()


  • Blood/tissue storage/culture container
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