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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Implantable Cardioverter Defibrillator VR
BOSTON SCIENTIFIC CORPORATION
D050
In Commercial Distribution

  • 00802526535024 ()


  • 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
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
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
D051
In Commercial Distribution

  • 00802526534140 ()


  • 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
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
PermaLife Cell Culture Bag, 120 mL - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL120-2G
Not in Commercial Distribution

  • 20816203024354 ()
  • 10816203024357 ()
PL120-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 120 mL, with SCD tubing
ORIGEN BIOMEDICAL, INC.
PL120N
Not in Commercial Distribution

  • 20816203024347 ()
  • 10816203024340 ()
PL120N

  • Blood/tissue storage/culture container
One female luer to eight spikes with 100cm of SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
F-8S100
Not in Commercial Distribution

  • 20816203024330 ()
  • 10816203024333 ()
F-8S100

  • Blood transfer set
CryoStore 50 EVA Freezing Bag, 10-30ml, "M3" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50M3
Not in Commercial Distribution

  • 20816203024316 ()
  • 10816203024319 ()
  • 00816203024312 ()
CS50M3

  • Blood/tissue storage/culture container
CryoStore 30 EVA Multi-Chamber Freezing Bag, 30ml, "M9" Tube Set
ORIGEN BIOMEDICAL, INC.
CS30M9
Not in Commercial Distribution

  • 20816203024309 ()
  • 10816203024302 ()
CS30M9

  • Blood/tissue storage/culture container
CryoStore 500 EVA Freezing Bag, 55-100ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500
Not in Commercial Distribution

  • 20816203024286 ()
  • 10816203024289 ()
  • 00816203024282 ()
CS500

  • Blood/tissue storage/culture container
CryoStore 250 EVA Freezing Bag, 30-70ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS250
Not in Commercial Distribution

  • 20816203024255 ()
  • 10816203024258 ()
  • 00816203024251 ()
CS250

  • Blood/tissue storage/culture container
CryoStore 50 EVA Freezing Bag, 10-30ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50N
Not in Commercial Distribution

  • 20816203024248 ()
  • 10816203024241 ()
  • 00816203024244 ()
CS50N

  • Blood/tissue storage/culture container
CryoStore 50 EVA Freezing Bag, 10-30ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS50
Not in Commercial Distribution

  • 20816203024231 ()
  • 10816203024234 ()
  • 00816203024237 ()
CS50

  • Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set, 8" donor tube
ORIGEN BIOMEDICAL, INC.
CS25XN
Not in Commercial Distribution

  • 20816203024224 ()
  • 10816203024227 ()
  • 00816203024220 ()
CS25XN

  • Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "N" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25N
Not in Commercial Distribution

  • 20816203024217 ()
  • 10816203024210 ()
  • 00816203024213 ()
CS25N

  • Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25F
Not in Commercial Distribution

  • 20816203024200 ()
  • 10816203024203 ()
  • 00816203024206 ()
CS25F

  • Blood/tissue storage/culture container
One 60ml syringe with one 0.22um filter and one 5um filter Single aseptically pouched
ORIGEN BIOMEDICAL, INC.
80HAS
Not in Commercial Distribution

  • 10816203024197 ()
  • 20816203024194 ()
80HAS

  • Blood transfer set
Four spikes to four male luers with 60cm SCD tubing, roller and pinch clamps
ORIGEN BIOMEDICAL, INC.
4S-4M60
Not in Commercial Distribution

  • 10816203024180 ()
4S-4M60

  • Blood transfer set
TissueVault, Cell and Tissue Freezing 9x18cm bag
ORIGEN BIOMEDICAL, INC.
TV0918
Not in Commercial Distribution

  • 20816203024156 ()
  • 10816203024159 ()
TV0918

  • Blood/tissue storage/culture container
One spike to one 3/8” barb with 12cm DMSO resistant tubing
ORIGEN BIOMEDICAL, INC.
S-38B12
Not in Commercial Distribution

  • 20816203024149 ()
  • 10816203024142 ()
S-38B12

  • Blood transfer set
PermaLife Cell Culture Bag, 70 mL - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL70-2G
Not in Commercial Distribution

  • 20816203024125 ()
  • 10816203024128 ()
PL70-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 30 mL with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL30M
Not in Commercial Distribution

  • 20816203024101 ()
  • 10816203024104 ()
PL30M

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x18cm
ORIGEN BIOMEDICAL, INC.
OW0918
Not in Commercial Distribution

  • 20816203024095 ()
  • 10816203024098 ()
  • 00816203024091 ()
OW0918

  • Blood/tissue storage/culture container
EVO Bag, 70-120ml Fill Volume, with luer connections and needle free valve with separate female to male tube set with 12cm of tubing
ORIGEN BIOMEDICAL, INC.
EV120 + F-M12
Not in Commercial Distribution

  • 20816203024071 ()
  • 10816203024074 ()
EV120 + F-M12

  • Blood/tissue storage/culture container
CryoStore 28 EVA Freezing Bag, 10-25ml, "V" Tube Set
ORIGEN BIOMEDICAL, INC.
CS28V
Not in Commercial Distribution

  • 20816203024064 ()
  • 10816203024067 ()
  • 00816203024060 ()
CS28V

  • Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "Y4" Tube Set
ORIGEN BIOMEDICAL, INC.
CS25Y4
Not in Commercial Distribution

  • 20816203024057 ()
  • 10816203024050 ()
  • 00816203024053 ()
CS25Y4

  • Blood/tissue storage/culture container
TissueVault, Cell and Tissue Freezing 9x9cm bag
ORIGEN BIOMEDICAL, INC.
TV0909
Not in Commercial Distribution

  • 20816203024019 ()
  • 10816203024012 ()
TV0909

  • Blood/tissue storage/culture container
One spike to one male luer with 50cm SCD tubing and pinch clamp
ORIGEN BIOMEDICAL, INC.
S-M50
Not in Commercial Distribution

  • 20816203023999 ()
  • 10816203023992 ()
S-M50

  • Blood transfer set
One spike to one spike port and two female luers with 12cm SCD tubing and pinch clamps
ORIGEN BIOMEDICAL, INC.
S-FFP12
Not in Commercial Distribution

  • 20816203023982 ()
  • 10816203023985 ()
S-FFP12

  • Blood transfer set
One spike to one female luer with 50cm of SCD tubing and pinch clamp
ORIGEN BIOMEDICAL, INC.
S-F50
Not in Commercial Distribution

  • 20816203023975 ()
  • 10816203023978 ()
S-F50

  • Blood transfer set
One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp
ORIGEN BIOMEDICAL, INC.
S-F10
Not in Commercial Distribution

  • 20816203023968 ()
  • 10816203023961 ()
S-F10

  • Blood transfer set
3ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
R3F-T15
Not in Commercial Distribution

  • 20816203023944 ()
  • 10816203023947 ()
R3F-T15

  • Blood transfer set
PermaLife Cell Culture Bag, 30 mL - no green vent cap
ORIGEN BIOMEDICAL, INC.
PL30-2G
Not in Commercial Distribution

  • 20816203023937 ()
  • 10816203023930 ()
PL30-2G

  • Blood/tissue storage/culture container
PermaLife Cell Culture Bag, 7 mL - no green vent capx
ORIGEN BIOMEDICAL, INC.
PL07-2G
Not in Commercial Distribution

  • 20816203023920 ()
  • 10816203023923 ()
PL07-2G

  • Blood/tissue storage/culture container
O-Wrap, overwrap pouch for freezing, 9x9cm
ORIGEN BIOMEDICAL, INC.
OW0909
Not in Commercial Distribution

  • 20816203023913 ()
  • 10816203023916 ()
  • 00816203023919 ()
OW0909

  • Blood/tissue storage/culture container
CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set, singly packed
ORIGEN BIOMEDICAL, INC.
CS25FP
Not in Commercial Distribution

  • 20816203023906 ()
  • 10816203023909 ()
CS25FP

  • Blood/tissue storage/culture container
20ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF20-T
Not in Commercial Distribution

  • 20816203023883 ()
  • 10816203023886 ()
15-RF20-T

  • Blood transfer set
12ml syringe on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-RF12-T
Not in Commercial Distribution

  • 20816203023876 ()
  • 10816203023879 ()
15-RF12-T

  • Blood transfer set
6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R6F-TA
Not in Commercial Distribution

  • 20816203023869 ()
  • 10816203023862 ()
15-R6F-TA

  • Blood transfer set
3ml syringe on a female luer with 15cm of SCD tubing
ORIGEN BIOMEDICAL, INC.
15-R3FT
Not in Commercial Distribution

  • 20816203023852 ()
  • 10816203023855 ()
15-R3FT

  • Blood transfer set
Needle-free vial spike, DMSO-resistant
ORIGEN BIOMEDICAL, INC.
VSV
Not in Commercial Distribution

  • 20816203023845 ()
  • 10816203023848 ()
VSV

  • Fluid transfer set, general-purpose
DMSO-Resistant Bag Spike with needle injection port
ORIGEN BIOMEDICAL, INC.
IBS
Not in Commercial Distribution

  • 10816203023800 ()
  • 20816203023807 ()
IBS

  • Blood transfer set
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