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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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
DMSO resistant Bag Spike w/ Needle-Free Injection Port
ORIGEN BIOMEDICAL, INC.
CBS
In Commercial Distribution

  • 10816203020045 ()
  • 20816203020042 ()


  • Intravenous fluid bag spike
Needle-free valve with caps, case of 10
ORIGEN BIOMEDICAL, INC.
NFV
In Commercial Distribution

  • 10816203020120 ()
  • 20816203020127 ()


  • Fluid transfer set, general-purpose
O-Wrap, overwrap pouch for freezing,19x36cm
ORIGEN BIOMEDICAL, INC.
OW1936
In Commercial Distribution

  • 00816203022615 ()
  • 10816203022612 ()


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

  • 00816203022608 ()
  • 10816203022605 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x18cm
ORIGEN BIOMEDICAL, INC.
OW0918
In Commercial Distribution

  • 00816203022592 ()
  • 10816203022599 ()


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

  • 00816203022585 ()
  • 10816203022582 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 4X19cm
ORIGEN BIOMEDICAL, INC.
OW0419
In Commercial Distribution

  • 10816203022575 ()
  • 00816203022578 ()


  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 24x36cm
ORIGEN BIOMEDICAL, INC.
OW2436
In Commercial Distribution

  • 00816203022257 ()
  • 10816203022254 ()


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

  • 00816203022226 ()
  • 10816203022223 ()


  • Blood/tissue storage/culture container
O-Wrap overwrap 3-layer pouch for freezing, 14x30cm
ORIGEN BIOMEDICAL, INC.
OW1430T
In Commercial Distribution

  • 00816203022202 ()
  • 10816203022209 ()


  • Blood/tissue storage/culture container
Cardiac Resynchronization Therapy Defibrillator
BOSTON SCIENTIFIC CORPORATION
G050
In Commercial Distribution

  • 00802526534454 ()


  • Cardiac resynchronization therapy implantable defibrillator
Cardiac Resynchronization Therapy Defibrillator
BOSTON SCIENTIFIC CORPORATION
G051
In Commercial Distribution

  • 00802526534478 ()


  • Cardiac resynchronization therapy implantable defibrillator
Implantable Cardioverter Defibrillator DR
BOSTON SCIENTIFIC CORPORATION
D053
In Commercial Distribution

  • 00802526534188 ()


  • Dual-chamber implantable defibrillator
Implantable Cardioverter Defibrillator DR
BOSTON SCIENTIFIC CORPORATION
D052
In Commercial Distribution

  • 00802526534164 ()


  • Dual-chamber implantable defibrillator
Implantable Cardioverter Defibrillator VR
BOSTON SCIENTIFIC CORPORATION
D050
In Commercial Distribution

  • 00802526535024 ()


  • Single-chamber implantable defibrillator
Implantable Cardioverter Defibrillator VR
BOSTON SCIENTIFIC CORPORATION
D051
In Commercial Distribution

  • 00802526534140 ()


  • Single-chamber implantable defibrillator
Implantable Cardioverter Defibrillator DR
BOSTON SCIENTIFIC CORPORATION
D002
In Commercial Distribution

  • 00802526533747 ()


  • Dual-chamber implantable defibrillator
Implantable Cardioverter Defibrillator DR
BOSTON SCIENTIFIC CORPORATION
D003
In Commercial Distribution

  • 00802526533761 ()


  • Dual-chamber implantable defibrillator
Implantable Cardioverter Defibrillator VR
BOSTON SCIENTIFIC CORPORATION
D001
In Commercial Distribution

  • 00802526533723 ()


  • Single-chamber implantable defibrillator
Implantable Cardioverter Defibrillator VR
BOSTON SCIENTIFIC CORPORATION
D000
In Commercial Distribution

  • 00802526533709 ()


  • Single-chamber implantable defibrillator
Cardiac Resynchronization Therapy Defibrillator
BOSTON SCIENTIFIC CORPORATION
G058
In Commercial Distribution

  • 00802526534515 ()


  • Cardiac resynchronization therapy implantable defibrillator
Cardiac Resynchronization Therapy Defibrillator
BOSTON SCIENTIFIC CORPORATION
G056
In Commercial Distribution

  • 00802526534492 ()


  • Cardiac resynchronization therapy implantable defibrillator
Four 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.
CC3
In Commercial Distribution

  • 20816203023319 ()
  • 10816203023312 ()
CC3

  • 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
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
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
In Commercial Distribution

  • 20816203023272 ()
  • 10816203023275 ()
  • 00816203023278 ()


  • Blood washing/centrifugation bag
Percutaneous Introducer Kit, singly aspetically pouched
ORIGEN BIOMEDICAL, INC.
PCTa
In Commercial Distribution

  • 10816203021721 ()


  • Vascular catheter introduction set, nonimplantable
Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes
ORIGEN BIOMEDICAL, INC.
PCT
In Commercial Distribution

  • 10816203023145 ()


  • Vascular catheter introduction set, nonimplantable
PermaLife Cell Culture Bag, 120ml, with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution

  • 10816203021769 ()
  • 00816203021762 ()


  • Patient-washing mitten
PermaLife Cell Culture bag, 750ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL750T
In Commercial Distribution

  • 20816203023630 ()
  • 10816203023633 ()
PL750T

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

  • 20816203023623 ()
  • 10816203023626 ()
PL325T

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

  • 20816203023616 ()
  • 10816203023619 ()
PL240T

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL120T
In Commercial Distribution

  • 20816203023609 ()
  • 10816203023602 ()
PL120T

  • Blood/tissue storage/culture container
PermaLife Cell Culture bag, 30ml, with SCD Tubing
ORIGEN BIOMEDICAL, INC.
PL30T
In Commercial Distribution

  • 10816203023596 ()
  • 20816203023593 ()
PL30T

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 2000ml, "P2" Set, packed with additional NFV cover
ORIGEN BIOMEDICAL, INC.
PL2000P2-2G
In Commercial Distribution

  • 10816203023411 ()


  • Blood/tissue storage/culture container
PermaLife cell culture bag, 1000ml, no green vent caps, "P" set, packed with additional spike port
ORIGEN BIOMEDICAL, INC.
PL1000P-2G
In Commercial Distribution

  • 10816203023404 ()
PL1000P-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 750ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL750-2G
In Commercial Distribution

  • 10816203023398 ()
PL750-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 500ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL500P-2G
In Commercial Distribution

  • 10816203023381 ()
PL500P-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 325ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL325-2G
In Commercial Distribution

  • 10816203023374 ()
PL325-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 240ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL240-2G
In Commercial Distribution

  • 10816203023367 ()
PL240-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 120ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL120-2G
In Commercial Distribution

  • 10816203023350 ()
PL120-2G

  • Blood/tissue storage/culture container
PermaLife cell culture bag, 70 ml, no green vent cap
ORIGEN BIOMEDICAL, INC.
PL70-2G
In Commercial Distribution

  • 10816203023343 ()
PL70-2G

  • Blood/tissue storage/culture container
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