Norav NR Series NR1207E-K-00-E-B10-01

GUDID 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.

Electrocardiographic ambulatory recorder

• Primary Device ID: 07290110253103
• NIH Device Record Key: 57a98bc6-69a9-4acc-bd42-f3b0e4e6a7c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norav NR Series
• Version Model Number: NR1207-E Kit
• Catalog Number: NR1207E-K-00-E-B10-01
• 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: info@norav.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110253103 [Primary]

FDA Product Code

• MWJ: Electrocardiograph, Ambulatory (Without Analysis)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-01

On-Brand Devices [Norav NR Series]

• 07290110255381: Norav Wireless ECG Acquisition Device NR3 for Resting-ECG with IEC type labelling.
• 07290110255374: Norav Wireless 3In1 Acquisition Device NR3 for Resting-ECG combined with Respiration and Body-Mo
• 07290110254896: Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Mo
• 07290110254889: Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respiration and Body-Mo
• 07290110254872: Norav Wireless 3In1 Acquisition Device NR2 for Resting-ECG combined with Respiration and Body-Mo
• 07290110254773: Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with AHA type labelling.
• 07290110254766: Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with AHA type labelling.
• 07290110254759: Norav Wireless ECG Acquisition Device NR2 for Resting-ECG with IEC type labelling.
• 07290110254711: Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
• 07290110254704: Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
• 07290110254698: Norav Ambulatory ECG Recording Device NR2 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
• 07290110254681: Kit includes: Norav Telemetry ECG Acquisition Device NR1 (UDI: 07290110253332) for Telemetry R
• 07290110254636: Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with AHA type la
• 07290110254629: Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with AHA type la
• 07290110254612: Norav Telemetry ECG Acquisition Device NR2 for Telemetry Resting-ECG Monitoring with IEC type la
• 07290110254605: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG M
• 07290110254582: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG M
• 07290110254575: Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG M
• 07290110254568: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254537) for Ambulatory ECG M
• 07290110254551: Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254520) for Ambulatory ECG M
• 07290110254544: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254513) for Ambulatory ECG M
• 07290110254537: Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110254520: Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110254513: Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110254506: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
• 07290110254483: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
• 07290110254476: Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110254421) for Ambulatory ECG M
• 07290110254469: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
• 07290110254452: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254438) for Ambulatory ECG M
• 07290110254445: Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 07290110254414) for Ambulatory ECG M
• 07290110254438: Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110254421: Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110254414: Norav Ambulatory ECG Recording Unit NR2 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110253332: Norav Telemetry ECG Acquisition Device NR1 for Telemetry Resting-ECG Monitoring with IEC type la
• 07290110253134: Norav Wireless 3In1 Acquisition Device NR1 for Resting-ECG combined with Respiration and Body-Mo
• 07290110253097: Norav Wireless ECG Acquisition Device NR1 for Resting-ECG with IEC type labelling.
• 07290110253073: Norav Ambulatory ECG Recording Device NR1 for Ambulatory ECG Monitoring (Holter-ECG) for maximum
• 07290110253066: Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110253059) for Ambulatory ECG M
• 07290110253059: Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110253042: Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 07290110253035) for Ambulatory ECG M
• 07290110253035: Norav Ambulatory ECG Recording Unit NR1 for Ambulatory ECG Monitoring (Holter-ECG) with 3 channe
• 07290110255404: Kit includes: Norav Wireless ECG Acquisition Device NR3 (UDI: 7290110255381) for Resting-ECG wit
• 07290110255343: Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG co
• 07290110255213: Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG co
• 07290110255206: Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG wit
• 07290110254919: Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110254889) for Resting-ECG co
• 07290110254902: Kit includes: Norav Wireless 3In1 Acquisition Device NR2 (UDI: 7290110254872) for Resting-ECG co
• 07290110254834: Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) for Resting-ECG wit
• 07290110254827: Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Resting-ECG wit
• 07290110254810: Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG wit