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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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SEER 1000 - 04250903200731

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
48 hour - Korean
Not in Commercial Distribution

  • 04250903200731 ()
2067634-068

  • Electrocardiographic ambulatory recorder

SEER 1000 - 04250903200724

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.
getemed Medizin- und Informationstechnik AG
24 hour - Korean
Not in Commercial Distribution

  • 04250903200724 ()
2067634-067

  • Electrocardiographic ambulatory recorder

PULSE - 00195377058539

PULSE LessRay Tablet, Labeled
Nuvasive, Inc.
1833071
In Commercial Distribution

  • 00195377058539 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377058508

PULSE LessRay Battery Pk, Tablet Labeled
Nuvasive, Inc.
1802417
In Commercial Distribution

  • 00195377058508 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377057037

PULSE LessRay Tablet Charging Station
Nuvasive, Inc.
1801815
In Commercial Distribution

  • 00195377057037 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377057020

PULSE LessRay GE C-arm Mount
Nuvasive, Inc.
1801814
In Commercial Distribution

  • 00195377057020 ()


  • Diagnostic x-ray digital imaging system workstation

Digital Expert Access - 00195278263919

DE Modality Connectivity Executable
GE HEALTHCARE
1
In Commercial Distribution

  • 00195278263919 ()


  • Diagnostic x-ray digital imaging system workstation

Messenger - 00086001142550

Messenger 6.0.0 Software Release
SPOK INC.
6.0.0
In Commercial Distribution

  • 00086001142550 ()


  • Alarm application software

LessRay - 00887517837363

LessRay Assembly Transformer Mount
Nuvasive, Inc.
8230029
In Commercial Distribution

  • 00887517837363 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517840653

LessRay Power Cord, 15ft Autolock
Nuvasive, Inc.
1675639
In Commercial Distribution

  • 00887517840653 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517840240

LessRay Phillips Screwdriver, Number 1
Nuvasive, Inc.
8230031
In Commercial Distribution

  • 00887517840240 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517814135

LessRay BNC Cable, 25 ft.
Nuvasive, Inc.
8230025
In Commercial Distribution

  • 00887517814135 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517811936

LessRay Table Clamp, Short
Nuvasive, Inc.
8230023
In Commercial Distribution

  • 00887517811936 ()


  • Diagnostic x-ray digital imaging system workstation

MPP-Plus - 18717775956614

No Description
Medical Measurement Systems B.V.
MPP-MT
In Commercial Distribution

  • 28717775956611 ()
  • 18717775956614 ()
  • 38717775956618 ()


  • Manometric gastrointestinal motility analysis system

LessRay - 00887517948328

LessRay Small Monitor Set
Nuvasive, Inc.
LRSMLMONMKT
In Commercial Distribution

  • 00887517948328 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517948311

LessRay Large Monitor Set
Nuvasive, Inc.
LRLRGMONMKT
In Commercial Distribution

  • 00887517948311 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517948304

LessRay Isolation Transformer Set
Nuvasive, Inc.
LRISOMKT
In Commercial Distribution

  • 00887517948304 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517948182

LessRay Table Array Set
Nuvasive, Inc.
LRCARTMKT
In Commercial Distribution

  • 00887517948182 ()


  • Diagnostic x-ray digital imaging system workstation

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

Norav NR Series - 07290110255404

Kit includes: Norav Wireless ECG Acquisition Device NR3 (UDI: 7290110255381) 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

  • 07290110255404 ()
NR1207E-K-00-E-B10-06

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110255381

Norav Wireless ECG Acquisition Device NR3 for Resting-ECG with IEC type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110255381 ()
NR1207E-D-00E-06

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110255374

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

Norav NR Series - 07290110255343

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

Norav NR Series - 07290110255213

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

Norav NR Series - 07290110255206

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 NR Series - 07290110254919

Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110254889) for Resting-ECG combined with Respiration and Body-Movement - AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors. Input cable with 5 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR1207-3 Kit
In Commercial Distribution

  • 07290110254919 ()
NR12073-K-00-UB10S5-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254902

Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) 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

  • 07290110254902 ()
NR12073-K-00-EB10S5-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254896

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

Norav NR Series - 07290110254889

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

  • 07290110254889 ()
NR12073-D-00U-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254872

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

  • 07290110254872 ()
NR12073-D-00E-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254834

Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) 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

  • 07290110254834 ()
NR1207E-K-00-U-B10-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254827

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

Norav NR Series - 07290110254810

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 Snap connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254810 ()
NR1207E-K-00-E-S10-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254780

Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) 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

  • 07290110254780 ()
NR1207E-K-00-E-B10-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254773

Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with AHA type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110254773 ()
NR1207E-D-00U-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254766

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

  • 07290110254766 ()
NR1207E-D-00U-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254759

Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with IEC type labelling.
NORAV MEDICAL LTD.
NR1207-E
In Commercial Distribution

  • 07290110254759 ()
NR1207E-D-00E-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254742

Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254711) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., max. 7days and AHA type labelling; Input cable with 10 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR1207 Kit
In Commercial Distribution

  • 07290110254742 ()
NR1207-K-00-U-S10-02

  • Electrocardiographic ambulatory recorder

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 - 07290110254711

Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, AHA type labelling.
NORAV MEDICAL LTD.
NR1207
In Commercial Distribution

  • 07290110254711 ()
NR1207-D-00U-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 - 07290110254698

Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum 7 days, with 12 channels, IEC type labelling.
NORAV MEDICAL LTD.
NR1207
In Commercial Distribution

  • 07290110254698 ()
NR1207-D-00E-02

  • 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 - 07290110254636

Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with AHA type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254636 ()
NR314T-D-00U-02

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254629

Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with AHA type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254629 ()
NR314T-D-00U-01

  • Electrocardiographic ambulatory recorder

Norav NR Series - 07290110254612

Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with IEC type labelling.
NORAV MEDICAL LTD.
NR314T
In Commercial Distribution

  • 07290110254612 ()
NR314T-D-00E-02

  • 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 - 07290110254582

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 5 Patient leads AHA type and Snap connectors.
NORAV MEDICAL LTD.
NR314 Kit
In Commercial Distribution

  • 07290110254582 ()
NR314-K-00-U-S5-02

  • Electrocardiographic ambulatory recorder
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