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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 - 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

ManoScan - 07290110361273

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

  • 07290110361273 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290110360368

GIFD WS PC, 3050 Win 10 with SW
Given Imaging, Inc.
FGS-0651
In Commercial Distribution

  • 07290110360368 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290110360344

GIFD laptop, 5480 Win 10 with SW
Given Imaging, Inc.
FGS-0649
In Commercial Distribution

  • 07290110360344 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101369578

ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101369059

AR v3.0 Software Upgrade kit
Given Imaging, Inc.
FGS-8031
In Commercial Distribution

  • 07290101369059 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101369042

ESO v3.0.1 SW Upgrade kit
Given Imaging, Inc.
FGS-8029
In Commercial Distribution

  • 07290101369042 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101366973

Assy, ManoScan Cart
Given Imaging, Inc.
FGS-8039
In Commercial Distribution

  • 07290101366973 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101366188

HRM/CLT WS, Dell 3020 W7
Given Imaging, Inc.
FGS-0582
In Commercial Distribution

  • 07290101366188 ()


  • Manometric gastrointestinal motility analysis system

Manoscan - 07290101366102

CLT v3.0 software upgrade
Given Imaging, Inc.
FGS-0580
In Commercial Distribution

  • 07290101366102 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365945

v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365938

CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365921

v3.0 software kit
Given Imaging, Inc.
FGS-0571
In Commercial Distribution

  • 07290101365921 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365914

Notebook, Dell E6440 Win 7
Given Imaging, Inc.
FGS-0570
In Commercial Distribution

  • 07290101365914 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365877

Dell 3020 Win XP GT
Given Imaging, Inc.
FGS-8046
In Commercial Distribution

  • 07290101365877 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365860

Dell 3020 Win 7
Given Imaging, Inc.
FGS-8045
In Commercial Distribution

  • 07290101365860 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365785

AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101365778

v3.0.1 Software kit
Given Imaging, Inc.
FGS-8028
In Commercial Distribution

  • 07290101365778 ()


  • Manometric gastrointestinal motility analysis system

Mano Scan - 07290101365754

ManoScan ESO Software
Given Imaging, Inc.
800022
In Commercial Distribution

  • 07290101365754 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365709

accessory kit
Given Imaging, Inc.
800000
In Commercial Distribution

  • 07290101365709 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365679

A550 Manometry Module
Given Imaging, Inc.
FGS-0559
In Commercial Distribution

  • 07290101365679 ()


  • Manometric gastrointestinal motility analysis system

NA - 07290101365655

Monitor, Dell P2214H 22 LED
Given Imaging, Inc.
FGS-0558
In Commercial Distribution

  • 07290101365655 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365600

Balloon, ARM 150cc, 10-pack
Given Imaging, Inc.
MSS-3598
In Commercial Distribution

  • 07290101365600 ()
  • 10884521740457 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365594

Balloon, ARM 600cc, 10-pack
Given Imaging, Inc.
MSS-2637
In Commercial Distribution

  • 07290101365594 ()
  • 10884521740464 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365587

Balloon, ARM 400cc, 10-pack
Given Imaging, Inc.
MSS-2599
In Commercial Distribution

  • 07290101365587 ()
  • 10884521740440 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365433

ESOZ accessory kit,PWS
Given Imaging, Inc.
FGS-8020
In Commercial Distribution

  • 07290101365433 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101365426

ESO accessory kit, PWS
Given Imaging, Inc.
FGS-8007
In Commercial Distribution

  • 07290101365426 ()


  • Manometric gastrointestinal motility analysis system

Manoscan - 07290101365402

PDU, holding plate & top case mount
Given Imaging, Inc.
150110
In Commercial Distribution

  • 07290101365402 ()


  • Manometric gastrointestinal motility analysis system

NA - 07290101365396

PDU, cal chamber mounting kit
Given Imaging, Inc.
FGS-8014
In Commercial Distribution

  • 07290101365396 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101364290

V A400 Module
Given Imaging, Inc.
4439
In Commercial Distribution

  • 07290101364290 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101364009

ManoScan AR Software
Given Imaging, Inc.
800024
In Commercial Distribution

  • 07290101364009 ()


  • Manometric gastrointestinal motility analysis system
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