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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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Powerheart® G5 Semi Automatic AED - 00812394023141

Powerheart® G5 Semi Automatic AED no battery or pads
Zoll Medical Corporation
G5S-19P0
In Commercial Distribution

  • 00812394023141 ()
G5S-19P0

  • Non-rechargeable public semi-automated external defibrillator

Powerheart® G5 Automatic AED - 00812394023134

Powerheart® G5 Automatic AED no battery or pads
Zoll Medical Corporation
G5A-19P0
In Commercial Distribution

  • 00812394023134 ()
G5A-19P0

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Automatic AED - 00812394023103

Powerheart G5 AED, Fully Automatic, Korean-International English, with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5A-19C
In Commercial Distribution

  • 00812394023103 ()
G5A-19C

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Semi Automatic AED - 00812394023097

Powerheart G5 AED, Semi Automatic, Korean- International English, with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5S-19C
In Commercial Distribution

  • 00812394023097 ()
G5S-19C

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Semi Automatic AED - 00812394022779

Powerheart G5 AED, Semi Automatic, Korean-International English, with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5S-19A
In Commercial Distribution

  • 00812394022779 ()
G5S-19A

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Automatic AED - 00812394022243

Powerheart G5 AED, Fully Automatic, Korean-International English, with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5A-19A
In Commercial Distribution

  • 00812394022243 ()
G5A-19A

  • Non-rechargeable public automated external defibrillator

Powerheart® G5 TSO Kit, Semi, US EN/LA ESP CPRD - 00812394021420

Powerheart® G5 AED, Semi-Automatic (US English / LA Spanish) with Intellisense Adult Electrodes with CPR Device and TSO Battery
Zoll Medical Corporation
G5S-80C-TSO
In Commercial Distribution

  • 00812394021420 ()
G5S-80C-TSO

  • Non-rechargeable public semi-automated external defibrillator

Powerheart® G5 TSO Kit, Semi, US EN/LA ESP - 00812394021413

Powerheart® G5 AED, Semi-Automatic (US English / LA Spanish) with Intellisense Adult Electrodes and TSO Battery
Zoll Medical Corporation
G5S-80A-TSO
In Commercial Distribution

  • 00812394021413 ()
G5S-80A-TSO

  • Non-rechargeable public semi-automated external defibrillator

Powerheart® G5 TSO Kit, Auto, US EN/LA ESP, CPRD - 00812394021406

Powerheart® G5 AED, Automatic (US English/LA Spanish) with Intellisense Adult Electrodes with CPR Device and TSO Battery
Zoll Medical Corporation
G5A-80C-TSO
In Commercial Distribution

  • 00812394021406 ()
G5A-80C-TSO

  • Non-rechargeable public automated external defibrillator

Powerheart® G5 TSO Kit, Auto, US EN/LA ESP - 00812394021390

Powerheart® G5 AED, Automatic (US English/LA Spanish) with Intellisense Adult Electrodes and TSO Battery
Zoll Medical Corporation
G5A-80A-TSO
In Commercial Distribution

  • 00812394021390 ()
G5A-80A-TSO

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Semi Auto - 00812394021307

Powerheart® G5 Semi Automatic AED, dual language(English/Spanish), no battery or pads
Zoll Medical Corporation
G5S-80P1
In Commercial Distribution

  • 00812394021307 ()
G5S-80P1

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5, Semi, US Eng/ESP LA - 00812394021291

Powerheart G5 AED, Semi Automatic, Loaner, Dual Language (English/Spanish)
Zoll Medical Corporation
G5S-80-L
In Commercial Distribution

  • 00812394021291 ()
G5S-80-L

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Kit, Semi, US Eng/ESP LA - 00812394021284

Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5S-80C
In Commercial Distribution

  • 00812394021284 ()
G5S-80C

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Kit, Semi, US Eng/ESP LA - 00812394021277

Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5S-80A
In Commercial Distribution

  • 00812394021277 ()
G5S-80A

  • Non-rechargeable public semi-automated external defibrillator

Powerheart® G5 Semi Automatic AED - 00812394021260

Powerheart® G5 Semi-Automatic AED no battery or pads
Zoll Medical Corporation
G5S-01P1
In Commercial Distribution

  • 00812394021260 ()
G5S-01P1

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Semi Automatic AED - 00812394021253

Powerheart G5 AED, Semi Automatic, Loaner, English
Zoll Medical Corporation
G5S-01-L
In Commercial Distribution

  • 00812394021253 ()
G5S-01-L

  • Non-rechargeable public semi-automated external defibrillator

Powerheart® G5 Semi Automatic AED - 00812394021246

Powerheart G5 AED, Semi Automatic, English, with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5S-01C
In Commercial Distribution

  • 00812394021246 ()
G5S-01C

  • Non-rechargeable public semi-automated external defibrillator

Powerheart® G5 Semi Automatic AED - 00812394021239

Powerheart G5 AED, Semi Automatic, English, with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5S-01A
In Commercial Distribution

  • 00812394021239 ()
G5S-01A

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Auto - 00812394021222

Powerheart® G5 Automatic AED, dual language(English/Spanish), no battery or pads
Zoll Medical Corporation
G5A-80P1
In Commercial Distribution

  • 00812394021222 ()
G5A-80P1

  • Non-rechargeable public automated external defibrillator

Powerheart G5, Auto, US Eng/ESP LA - 00812394021215

Powerheart G5 AED, Fully Automatic, Loaner, Dual Language (English/Spanish)
Zoll Medical Corporation
G5A-80-L
In Commercial Distribution

  • 00812394021215 ()
G5A-80-L

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Kit, Auto, US Eng/ESP LA - 00812394021208

Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5A-80C
In Commercial Distribution

  • 00812394021208 ()
G5A-80C

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Kit, Auto, US Eng/ESP LA - 00812394021192

Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5A-80A
In Commercial Distribution

  • 00812394021192 ()
G5A-80A

  • Non-rechargeable public automated external defibrillator

Powerheart® G5 Automatic AED - 00812394021185

Powerheart® G5 Automatic AED no battery or pads
Zoll Medical Corporation
G5A-01P1
In Commercial Distribution

  • 00812394021185 ()
G5A-01P1

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Automatic AED - 00812394021178

Powerheart G5 AED, Fully Automatic, Loaner, English
Zoll Medical Corporation
G5A-01-L
In Commercial Distribution

  • 00812394021178 ()
G5A-01-L

  • Non-rechargeable public automated external defibrillator

Powerheart® G5 Automatic AED - 00812394021161

Powerheart G5 AED, Fully Automatic, English, with Intellisense Adult Pads with CPR feedback device and Battery
Zoll Medical Corporation
G5A-01C
In Commercial Distribution

  • 00812394021161 ()
G5A-01C

  • Non-rechargeable public automated external defibrillator

Powerheart® G5 Automatic AED - 00812394021154

Powerheart G5 AED, Fully Automatic, English, with Intellisense Adult Pads and Battery
Zoll Medical Corporation
G5A-01A
In Commercial Distribution

  • 00812394021154 ()
G5A-01A

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Kit, Auto, US Eng/ESP LA - 00812394020577

Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish),no battery or pads
Cardiac Science Corporation
G5A-80P0
In Commercial Distribution

  • 00812394020577 ()
G5A-80P0

  • Non-rechargeable public automated external defibrillator

Powerheart G5 Kit, Semi, US Eng/ESP LA - 00812394020560

Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),no battery or pads
Cardiac Science Corporation
G5S-80P0
In Commercial Distribution

  • 00812394020560 ()
G5S-80P0

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Kit, Semi, US Eng/ESP LA - 00812394020553

Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),with Intellisense Adult Pads and Battery
Cardiac Science Corporation
G5S-80A
In Commercial Distribution

  • 00812394020553 ()
G5S-80A

  • Non-rechargeable public semi-automated external defibrillator

Powerheart G5 Kit, Auto, US Eng/ESP LA - 00812394020546

Powerheart G5 AED, Fully Automatic, Dual Language (English/Spanish),with Intellisense Adult Pads and Battery
Cardiac Science Corporation
G5A-80A
In Commercial Distribution

  • 00812394020546 ()
G5A-80A

  • Non-rechargeable public automated external defibrillator

NA - 07613154475179

ZEISS MICROSCOPE TRACKER
Stryker Leibinger GmbH & Co. KG
6000-075-000
In Commercial Distribution

  • 07613154475179 ()
6000-075-000

  • Multi-purpose stereotactic surgery system

OPTIS™ - 00812059021994

Installation Kit
LIGHTLAB IMAGING, INC.
Mobile System
In Commercial Distribution

  • 00812059021994 ()
C408667

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021987

Installation Kit
LIGHTLAB IMAGING, INC.
Mobile System
In Commercial Distribution

  • 00812059021987 ()
C408666

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021925

Software Upgrade
LIGHTLAB IMAGING, INC.
Software Upgrade
In Commercial Distribution

  • 00812059021925 ()
E4-STD-WW

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021918

Software Upgrade
LIGHTLAB IMAGING, INC.
Metallic Stent Optimization Software
In Commercial Distribution

  • 00812059021918 ()
E4-FULL-WW

  • Coronary optical coherence tomography system

C7-XR™ - 00812059021536

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
C.0.4 Software Upgrade
In Commercial Distribution

  • 00812059021536 ()
15211-01

  • Coronary optical coherence tomography system

ILUMIEN™ - 00812059021482

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1 Software
In Commercial Distribution

  • 00812059021482 ()
100074942

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021444

Tableside Controller
LIGHTLAB IMAGING, INC.
C408663
In Commercial Distribution

  • 00812059021444 ()
C408663

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021437

Upgrade Kit
LIGHTLAB IMAGING, INC.
Mobile System
In Commercial Distribution

  • 00812059021437 ()
C408662

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021390

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution

  • 00812059021390 ()
C408657

  • Coronary optical coherence tomography system

ILUMIEN™ - 00812059021383

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
OPTIS™ E.2 Software
In Commercial Distribution

  • 00812059021383 ()
C408656

  • Coronary optical coherence tomography system

OPTIS™ - 00812059020126

Mobile Workstation
LIGHTLAB IMAGING, INC.
C408653
In Commercial Distribution

  • 00812059020126 ()
C408653

  • Coronary optical coherence tomography system

OPTIS™ - 00812059020003

Installation Kit
LIGHTLAB IMAGING, INC.
Integrated System
In Commercial Distribution

  • 00812059020003 ()
C408654

  • Coronary optical coherence tomography system

CryoPRO™-5 - B039SGI04420

CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system

SynGenX®-1000 - B039SGI03050

SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set

SynGenX®-1000 - B039SGI0120010

SynGenX®-1000 Docking Station
Thermogenesis Corp.
SGI-0120-01
In Commercial Distribution

  • B039SGI0120010 ()
  • B039SGI0120011 ()


  • Noninvasive device battery charger

CryoPRO™-2 - B039SGI00910

CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system

SynGenX®-1000 - B039SGI0046010

SynGenX®-1000 Control Module
Thermogenesis Corp.
SGI-0046-01
In Commercial Distribution

  • B039SGI0046010 ()
  • B039SGI0046011 ()


  • Blood component separator, automated

NA - 07613252516941

ZEISS NC4 MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-055-000
In Commercial Distribution

  • 07613252516941 ()
7700-055-000

  • Multi-purpose stereotactic surgery system

NA - 07613252516934

LEICA MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-065-000
In Commercial Distribution

  • 07613252516934 ()
7700-065-000

  • Multi-purpose stereotactic surgery system
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