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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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Norav NR Series - 07290110254728

Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254698) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and IEC type labelling; Input cable with 10 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR1207 Kit
In Commercial Distribution

  • 07290110254728 ()
NR1207-K-00-E-S10-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254704

Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, AHA type labelling.
NORAV MEDICAL LTD.
NR1207
In Commercial Distribution

  • 07290110254704 ()
NR1207-D-00U-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254681

Kit includes: Norav Telemetry ECG Acquisition Device NR1 (UDI: 07290110253332) for Telemetry Resting-ECG Monitoring with AHA type labelling; Input cable with 5 Patient leads, AHA type labelling.
NORAV MEDICAL LTD.
NR314T Kit
In Commercial Distribution

  • 07290110254681 ()
NR314T-K-00-U-S5-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254605

Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 7 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR314 Kit
In Commercial Distribution

  • 07290110254605 ()
NR314-K-00-U-S7-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254438

Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 48h recording capacity and AHA type labelling.
NORAV MEDICAL LTD.
NR302
In Commercial Distribution

  • 07290110254438 ()
NR302-D-00U-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254414

Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 48h recording capacity and IEC type labelling.
NORAV MEDICAL LTD.
NR302
In Commercial Distribution

  • 07290110254414 ()
NR302-D-00E-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253141

Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors. Input cable with 5 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR1207-3 Kit
In Commercial Distribution

  • 07290110253141 ()
NR12073-K-00-EB10S5-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253134

Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respiration and Body-Movement - IEC type labelling.
NORAV MEDICAL LTD.
NR1207-3
In Commercial Distribution

  • 07290110253134 ()
NR12073-D-00E-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253103

Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110253103 ()
NR1207E-K-00-E-B10-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253097

Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with IEC type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110253097 ()
NR1207E-D-00E-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253080

Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 7290110253073) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and IEC type labelling; Input cable with 10 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR1207 Kit
In Commercial Distribution

  • 07290110253080 ()
NR1207-K-00-E-S10-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253073

Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, IEC type labelling.
NORAV MEDICAL LTD.
NR1207
In Commercial Distribution

  • 07290110253073 ()
NR1207-D-00E-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253066

Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110253059) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and IEC type labelling; Input cable with 7 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR314 Kit
In Commercial Distribution

  • 07290110253066 ()
NR314-K-00-E-S7-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253059

Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 14 days recording capacity and IEC type labelling.
NORAV MEDICAL LTD.
NR314
In Commercial Distribution

  • 07290110253059 ()
NR314-D-00E-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253042

Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110253035) for Ambulatory ECG Monitoring (Holter-ECG), 3 channels, max. 48h and IEC type labelling; Input cable with 7 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR302 Kit
In Commercial Distribution

  • 07290110253042 ()
NR302-K-00-E-S7-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110253035

Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 48h recording capacity and IEC type labelling.
NORAV MEDICAL LTD.
NR302
In Commercial Distribution

  • 07290110253035 ()
NR302-D-00E-01

  • Electrocardiographic ambulatory recorder

Digistat Smart Central - 17350097870032

Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
ASCOM UMS SRL
SW000754
In Commercial Distribution

  • 17350097870032 ()


  • Alarm application software

Ascom - 17350088671273

No Description
Ascom (Sweden) AB
Unite Connect for Clinical Systems
In Commercial Distribution

  • 17350088671273 ()
SW000466

  • Alarm application software

Ascom - 17350088670016

No Description
Ascom (Sweden) AB
Cardiomax
In Commercial Distribution

  • 17350088670016 ()
SW000466

  • Alarm application software

Ascom - 17350088670009

No Description
Ascom (Sweden) AB
Mobile Monitoring Gateway (MMG)
In Commercial Distribution

  • 17350088670009 ()
SW000400

  • Alarm application software
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