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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 Size Device Size Type Device Class Implantable

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Filter Combo Pack for PR System One
SUNSET HEALTHCARE SOLUTIONS, INC.
APAR008CF1009NTCOMBO
In Commercial Distribution

  • 00848530083687 ()


  • CPAP/BPAP unit ambient air filter, single-use
One Step HCG Urine Pregnancy Test Strip
Beijing Choice Electronic Technology Co., Ltd.
HCG (1.0)
In Commercial Distribution

  • 00846841060748 ()
  • 10846841060745 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
ONE STEP HCG URINE PREGNANCY TEST (STRIP)
Beijing Choice Electronic Technology Co., Ltd.
HCG(3mm)
In Commercial Distribution

  • 00846841060700 ()
  • 10846841060707 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
One Step HCG Urine Pregnancy Test Strip
Beijing Choice Electronic Technology Co., Ltd.
HCG (3.0)
In Commercial Distribution

  • 00846841012365 ()
  • 10846841012362 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
CUSTOM PACK 8V49R 20PK SUPP ONE WAY
MEDTRONIC, INC.
8V49R
Not in Commercial Distribution

  • 20643169628506 ()
  • 00643169628496 ()


  • Cardiopulmonary bypass system blood tubing set
CANN CB77016 ART ONE PIECE 16FR 17L
MEDTRONIC, INC.
CB77016
In Commercial Distribution

  • 00643169560949 ()

  • Catheter Gauge: 16.0 French


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
CANN CB77014 ART ONE PIECE 14FR 17L
MEDTRONIC, INC.
CB77014
In Commercial Distribution

  • 00643169560932 ()

  • Catheter Gauge: 14.0 French


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
CANN CB77012 ART ONE PIECE 12FR 17L
MEDTRONIC, INC.
CB77012
In Commercial Distribution

  • 00643169560925 ()

  • Catheter Gauge: 12.0 French


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
CANN CB77010 ART ONE PIECE 10FR 17L
MEDTRONIC, INC.
CB77010
In Commercial Distribution

  • 00643169560918 ()

  • Catheter Gauge: 10.0 French


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
CANN CB77008 ART ONE PIECE 8FR 17L
MEDTRONIC, INC.
CB77008
In Commercial Distribution

  • 00643169560901 ()

  • Catheter Gauge: 8.0 French


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
CUSTOM PACK BB8Y52R 10PK SUPP ONE W
MEDTRONIC, INC.
BB8Y52R
In Commercial Distribution

  • 20643169663637 ()
  • 00643169663626 ()


  • Cardiopulmonary bypass system blood tubing set
PEDI*PADZ REDUCED ENERGY ELECTRODE - ONE PAIR
Zoll Medical Corporation
8900-0401
In Commercial Distribution

  • 00847946016302 ()

  • 10.0" X 9.0" X 3.0"


  • Rechargeable professional automated external defibrillator
ONE STEP PEDIATRIC CPR ELECTRODE (1 pair)
Zoll Medical Corporation
8900-000219-01
Not in Commercial Distribution

  • 00847946016197 ()
  • 10847946016194 ()

  • 9.3" X 8.5" X 1.0"


  • Rechargeable professional automated external defibrillator
Kit, Accessory Aquilion One, 1 per Each
TIDI PRODUCTS, LLC
9105F
Not in Commercial Distribution

  • 00618125187102 ()


  • Multifunction body cushion
3 pk of System One Tabbed Filter
SUNSET HEALTHCARE SOLUTIONS, INC.
CF1009-3
In Commercial Distribution

  • 00848530036232 ()


  • CPAP/BPAP unit ambient air filter, single-use
ONE PIECE AEROSOL MASK, CHILD, ELEPHANT DESIGN
BESMED HEALTH BUSINESS CORP.
OM-82420
In Commercial Distribution

  • 04716770824208 ()


  • Respiratory oxygen therapy system
Canister for VT• One - 150ml luer lock
CARILEX MEDICAL, INC.
S1004-6030
In Commercial Distribution

  • 04719873695676 ()
  • 04719873695669 ()
  • 04719873695683 ()
  • 14719873695666 ()
  • 24719873695663 ()


  • Negative-pressure wound therapy system canister
VT•One 60 Days SYS Global Carilex
CARILEX MEDICAL, INC.
S1004-0022
In Commercial Distribution

  • 04713616090858 ()


  • Negative-pressure wound therapy system pump, electric
blood uric acid control solution: one vial
VISGENEER, INC.
eB-series
Not in Commercial Distribution

  • 04712558769037 ()


  • Uric acid IVD, control
Mayo Full Curved Scissors, One Serrated Blade
SCANLAN INTERNATIONAL INC
1011-21
In Commercial Distribution

  • 00846159030464 ()
1011-21

  • General-purpose surgical scissors, reusable
INTAKE VALVE COMPLETE -ALL IN ONE,POLYCARBONATE
BESMED HEALTH BUSINESS CORP.
RE-21210
In Commercial Distribution

  • 04716770212104 ()


  • Pulmonary resuscitator, manual, reusable
Domus 2s with 5" One Piece Pad
Wellell Inc.
Domus 2s with 5" One Piece Pad
In Commercial Distribution

  • 14713025002487 ()
  • 04713025002480 ()


  • Alternating-pressure chair cushion, reusable
Scissors, Lister Bandage One Large Ring 8"
MCKESSON MEDICAL-SURGICAL INC.
43-1-242
In Commercial Distribution

  • 00612479198432 ()


  • Bandage scissors, reusable
CREO ONE 7.5x55mm Robotic, HA Modular Screw
GLOBUS MEDICAL, INC.
1134.1756S
In Commercial Distribution

  • 00193982453220 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE 7.5x50mm Robotic, HA Modular Screw
GLOBUS MEDICAL, INC.
1134.1751S
In Commercial Distribution

  • 00193982453206 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE 7.5x45mm Robotic, HA Modular Screw
GLOBUS MEDICAL, INC.
1134.1746S
In Commercial Distribution

  • 00193982453183 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE 7.5x40mm Robotic, HA Modular Screw
GLOBUS MEDICAL, INC.
1134.1741S
In Commercial Distribution

  • 00193982453169 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE 7.5x35mm Robotic, HA Modular Screw
GLOBUS MEDICAL, INC.
1134.1736S
In Commercial Distribution

  • 00193982453145 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE 6.5x55mm Robotic, HA Modular Screw
GLOBUS MEDICAL, INC.
1134.1656S
In Commercial Distribution

  • 00193982452841 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE 6.5x50mm Robotic, HA Modular Screw
GLOBUS MEDICAL, INC.
1134.1651S
In Commercial Distribution

  • 00193982452827 ()


  • Trans-facet-screw internal spinal fixation system, sterile
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