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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Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 5 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR314 Kit
In Commercial Distribution

  • 07290110254575 ()
NR314-K-00-U-S5-01

  • Electrocardiographic ambulatory recorder
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 3 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR314 Kit
In Commercial Distribution

  • 07290110254568 ()
NR314-K-00-U-S3-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG Monitoring (Holter-ECG), 3 ch., max. 14 days and AHA type labelling; Input cable with 3 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR314 Kit
In Commercial Distribution

  • 07290110254551 ()
NR314-K-00-U-S3-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254513) 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

  • 07290110254544 ()
NR314-K-00-E-S7-02

  • Electrocardiographic ambulatory recorder
Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channels, max. 14 days recording capacity and AHA type labelling.
NORAV MEDICAL LTD.
NR314
In Commercial Distribution

  • 07290110254537 ()
NR314-D-00U-02

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

  • 07290110254520 ()
NR314-D-00U-01

  • Electrocardiographic ambulatory recorder
Norav Ambulatory ECG Recording Unit NR2 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

  • 07290110254513 ()
NR314-D-00E-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG Monitoring (Holter-ECG), 3 channels, max. 48h and AHA type labelling; Input cable with 7 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR302 Kit
In Commercial Distribution

  • 07290110254506 ()
NR302-K-00-U-S7-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG Monitoring (Holter-ECG), 3 channels, max. 48h and AHA type labelling; Input cable with 5 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR302 Kit
In Commercial Distribution

  • 07290110254483 ()
NR302-K-00-U-S5-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254421) for Ambulatory ECG Monitoring (Holter-ECG), 3 channels, max. 48h and AHA type labelling; Input cable with 5 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR302 Kit
In Commercial Distribution

  • 07290110254476 ()
NR302-K-00-U-S5-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG Monitoring (Holter-ECG), 3 channels, max. 48h and AHA type labelling; Input cable with 3 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR302 Kit
In Commercial Distribution

  • 07290110254469 ()
NR302-K-00-U-S3-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG Monitoring (Holter-ECG), 3 channels, max. 48h and AHA type labelling; Input cable with 3 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR302 Kit
In Commercial Distribution

  • 07290110254452 ()
NR302-K-00-U-S3-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254414) 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

  • 07290110254445 ()
NR302-K-00-E-S7-02

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

  • 07290110254421 ()
NR302-D-00U-01

  • Electrocardiographic ambulatory recorder
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 Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with IEC type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110253332 ()
NR314T-D-00E-01

  • 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. 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 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
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 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
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 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
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 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
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 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
LessRay Remote, Wired
Nuvasive, Inc.
8230022
In Commercial Distribution

  • 00887517805997 ()


  • Diagnostic x-ray digital imaging system workstation
ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system
AR v3.0 Software Upgrade kit
Given Imaging, Inc.
FGS-8031
In Commercial Distribution

  • 07290101369059 ()


  • Manometric gastrointestinal motility analysis system
ESO v3.0.1 SW Upgrade kit
Given Imaging, Inc.
FGS-8029
In Commercial Distribution

  • 07290101369042 ()


  • Manometric gastrointestinal motility analysis system
Assy, ManoScan Cart
Given Imaging, Inc.
FGS-8039
In Commercial Distribution

  • 07290101366973 ()


  • Manometric gastrointestinal motility analysis system
HRM/CLT WS, Dell 3020 W7
Given Imaging, Inc.
FGS-0582
In Commercial Distribution

  • 07290101366188 ()


  • Manometric gastrointestinal motility analysis system
CLT v3.0 software upgrade
Given Imaging, Inc.
FGS-0580
In Commercial Distribution

  • 07290101366102 ()


  • Manometric gastrointestinal motility analysis system
v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system
CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system
v3.0 software kit
Given Imaging, Inc.
FGS-0571
In Commercial Distribution

  • 07290101365921 ()


  • Manometric gastrointestinal motility analysis system
Notebook, Dell E6440 Win 7
Given Imaging, Inc.
FGS-0570
In Commercial Distribution

  • 07290101365914 ()


  • Manometric gastrointestinal motility analysis system
Dell 3020 Win XP GT
Given Imaging, Inc.
FGS-8046
In Commercial Distribution

  • 07290101365877 ()


  • Manometric gastrointestinal motility analysis system
Dell 3020 Win 7
Given Imaging, Inc.
FGS-8045
In Commercial Distribution

  • 07290101365860 ()


  • Manometric gastrointestinal motility analysis system
AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system
v3.0.1 Software kit
Given Imaging, Inc.
FGS-8028
In Commercial Distribution

  • 07290101365778 ()


  • Manometric gastrointestinal motility analysis system
ManoScan ESO Software
Given Imaging, Inc.
800022
In Commercial Distribution

  • 07290101365754 ()


  • Manometric gastrointestinal motility analysis system
accessory kit
Given Imaging, Inc.
800000
In Commercial Distribution

  • 07290101365709 ()


  • Manometric gastrointestinal motility analysis system
A550 Manometry Module
Given Imaging, Inc.
FGS-0559
In Commercial Distribution

  • 07290101365679 ()


  • Manometric gastrointestinal motility analysis system
Monitor, Dell P2214H 22 LED
Given Imaging, Inc.
FGS-0558
In Commercial Distribution

  • 07290101365655 ()


  • Manometric gastrointestinal motility analysis system
Balloon, ARM 150cc, 10-pack
Given Imaging, Inc.
MSS-3598
In Commercial Distribution

  • 07290101365600 ()
  • 10884521740457 ()


  • Manometric gastrointestinal motility analysis system
Balloon, ARM 600cc, 10-pack
Given Imaging, Inc.
MSS-2637
In Commercial Distribution

  • 07290101365594 ()
  • 10884521740464 ()


  • Manometric gastrointestinal motility analysis system
Balloon, ARM 400cc, 10-pack
Given Imaging, Inc.
MSS-2599
In Commercial Distribution

  • 07290101365587 ()
  • 10884521740440 ()


  • Manometric gastrointestinal motility analysis system
ESOZ accessory kit,PWS
Given Imaging, Inc.
FGS-8020
In Commercial Distribution

  • 07290101365433 ()


  • Manometric gastrointestinal motility analysis system
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