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, 325ml, "L" Set with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325L
In Commercial Distribution

  • 10816203022995 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml, "T" Set, 4mil FEP
ORIGEN BIOMEDICAL, INC.
PL120T
In Commercial Distribution

  • 10816203022377 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 750ml
ORIGEN BIOMEDICAL, INC.
PL750
In Commercial Distribution

  • 10816203021851 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 500ml, "P" Set, packed with additional PVC spike port
ORIGEN BIOMEDICAL, INC.
PL500P
In Commercial Distribution

  • 10816203021844 ()


  • 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
325ml Cell Culture bag, FEP, 4th Generation
ORIGEN BIOMEDICAL, INC.
PL325-4G
In Commercial Distribution

  • 10816203021820 ()


  • 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, 240ml, "K" Set
ORIGEN BIOMEDICAL, INC.
PL240K
In Commercial Distribution

  • 10816203021790 ()


  • 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, 1000ml, "P" Set, packed with additional spike port
ORIGEN BIOMEDICAL, INC.
PL1000P
In Commercial Distribution

  • 10816203021752 ()


  • 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
PermaLife Cell Culture Bag, 70ml
ORIGEN BIOMEDICAL, INC.
PL70
In Commercial Distribution

  • 10816203020182 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 325ml
ORIGEN BIOMEDICAL, INC.
PL325
In Commercial Distribution

  • 10816203020175 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30ml
ORIGEN BIOMEDICAL, INC.
PL30
In Commercial Distribution

  • 10816203020168 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 240ml
ORIGEN BIOMEDICAL, INC.
PL240
In Commercial Distribution

  • 10816203020151 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml
ORIGEN BIOMEDICAL, INC.
PL120
In Commercial Distribution

  • 10816203020144 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 7ml
ORIGEN BIOMEDICAL, INC.
PL07
In Commercial Distribution

  • 10816203020137 ()


  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120ml, with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL120M
In Commercial Distribution

  • 10816203021769 ()
  • 00816203021762 ()


  • Patient-washing mitten
Percutaneous Introducer Tray for Reinforced Dual Lumen Cannula, 13F-32F sizes
ORIGEN BIOMEDICAL, INC.
PCT
Not in Commercial Distribution

  • 10816203023145 ()


  • Vascular catheter introduction set, nonimplantable
Percutaneous Introducer Kit, singly aspetically pouched
ORIGEN BIOMEDICAL, INC.
PCTa
In Commercial Distribution

  • 10816203021721 ()


  • Vascular catheter introduction set, nonimplantable
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
Not 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
Not 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
Not in Commercial Distribution

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


  • Blood washing/centrifugation bag
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
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
Implantable Cardioverter Defibrillator DR
BOSTON SCIENTIFIC CORPORATION
D003
In Commercial Distribution

  • 00802526533761 ()


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

  • 00802526533747 ()


  • 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
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
Cardiac Resynchronization Therapy Defibrillator
BOSTON SCIENTIFIC CORPORATION
G051
In Commercial Distribution

  • 00802526534478 ()


  • Cardiac resynchronization therapy implantable defibrillator
Cardiac Resynchronization Therapy Defibrillator
BOSTON SCIENTIFIC CORPORATION
G050
In Commercial Distribution

  • 00802526534454 ()


  • Cardiac resynchronization therapy implantable defibrillator
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
Not in Commercial Distribution

  • 00816203022202 ()
  • 10816203022209 ()


  • Blood/tissue storage/culture container
Needle-free valve with caps, case of 10
ORIGEN BIOMEDICAL, INC.
NFV
In Commercial Distribution

  • 10816203020120 ()
  • 20816203020127 ()


  • Fluid transfer set, general-purpose
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
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
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
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