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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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Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-BAA-XXXXX
In Commercial Distribution

  • 00812345027105 ()


  • Electrocardiographic ambulatory recorder
GIFD WS PC, Win 10 with SW
Given Imaging, Inc.
FGS-0684
In Commercial Distribution

  • 07290110361273 ()


  • Manometric gastrointestinal motility analysis system
GIFD WS PC, 3050 Win 10 with SW
Given Imaging, Inc.
FGS-0651
In Commercial Distribution

  • 07290110360368 ()


  • Manometric gastrointestinal motility analysis system
GIFD laptop, 5480 Win 10 with SW
Given Imaging, Inc.
FGS-0649
In Commercial Distribution

  • 07290110360344 ()


  • Manometric gastrointestinal motility analysis system
Norav Wireless 3In1 Acquisition Device NR3 for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.
NORAV MEDICAL LTD.
NR1207-3
In Commercial Distribution

  • 07290110255374 ()
NR12073-D-00E-06

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Special edition for TASHIO
NORAV MEDICAL LTD.
NR1207-3 Kit
In Commercial Distribution

  • 07290110255343 ()
NR12073-K-00-E-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Special edition for TASHIO
NORAV MEDICAL LTD.
NR1207-3 Kit
In Commercial Distribution

  • 07290110255213 ()
NR12073-K-00-E-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Special edition for TASHIO
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110255206 ()
NR1207E-K-00-E-01

  • Electrocardiographic ambulatory recorder
Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling.
NORAV MEDICAL LTD.
NR1207-3
In Commercial Distribution

  • 07290110254896 ()
NR12073-D-00U-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254827 ()
NR1207E-K-00-U-B10-01

  • Electrocardiographic ambulatory recorder
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