Norav 1200 Series ECGUSB1DEX-K-00-01

GUDID 07290110255435

Kit includes: Single Channel ECG Acquisition Module (DI no.: 07290110251062) for integration in other Medical Devices (GE Wuxi). Special edition for GE Health Care.

NORAV MEDICAL LTD.

Electrocardiographic signal amplifier

• Primary Device ID: 07290110255435
• NIH Device Record Key: 879381cd-a046-4245-a13f-de614caa795b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norav 1200 Series
• Version Model Number: ECGUSB1DEX Kit
• Catalog Number: ECGUSB1DEX-K-00-01
• Company DUNS: 514773159
• Company Name: NORAV MEDICAL LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97249893001
• Email: support@norav.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110255435 [Primary]

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-11

Devices Manufactured by NORAV MEDICAL LTD.

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• 07290110253080 - Norav NR Series: 2019-11-08 Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 7290110253073) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., ma
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• 07290110254728 - Norav NR Series: 2019-11-08 Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254698) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., ma
• 07290110254742 - Norav NR Series: 2019-11-08 Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254711) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., ma
• 07290110254780 - Norav NR Series: 2019-11-08 Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) for Resting-ECG with IEC type labelling.