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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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AcQMap - 00857042007074

Ampere® Adapter Cable AcQMap® Ablation Catheter
ACUTUS MEDICAL, INC.
800430
Not in Commercial Distribution

  • 00857042007074 ()
800430

  • Cardiac mapping system

AcQMap - 00857042007050

AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution

  • 00857042007050 ()
800254

  • Cardiac mapping system

HealthView ECG Manager - 00857560008010

The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review. The product does not modify the original ECG waveform and does not provide an automated ECG analysis.
LUMEDX CORPORATION
1.2.5
In Commercial Distribution

  • 00857560008010 ()
113-01003

  • Cardiology information system application software

WorkMate™ - 05415067010605

Display Workstation
ST. JUDE MEDICAL, INC.
H701060
In Commercial Distribution

  • 05415067010605 ()
H701060

  • Cardiac catheterization monitoring system

MediGuide™ - 05415067009807

Power Supply
ST. JUDE MEDICAL, INC.
H700980
In Commercial Distribution

  • 05415067009807 ()
H700980

  • Cardiac mapping system

MediGuide™ - 05415067009791

Power Supply
ST. JUDE MEDICAL, INC.
H700979
In Commercial Distribution

  • 05415067009791 ()
H700979

  • Cardiac mapping system

WorkMate Claris™ - 05415067009777

Display Workstation
ST. JUDE MEDICAL, INC.
H700977
In Commercial Distribution

  • 05415067009777 ()
H700977

  • Cardiac catheterization monitoring system

EnSite™ Velocity™ - 05415067008718

Workstation Accessory Kit
ST. JUDE MEDICAL, INC.
100045484
In Commercial Distribution

  • 05415067008718 ()
100045484

  • Electrical-only medical device connection cable, reusable

MediGuide™ - 05415067006752

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006752 ()
H700675

  • Cardiac mapping system

MediGuide™ - 05415067006721

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006721 ()
H700672

  • Cardiac mapping system
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