Norav 1200 Series PC-ECG 1200W2-D-04U-02

GUDID 04260498565054

PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling; Special edition for GE Health Care.

Norav Medical GmbH

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• Primary Device ID: 04260498565054
• NIH Device Record Key: 7b9560f4-9689-4ced-8305-e68893a170d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norav 1200 Series PC-ECG
• Version Model Number: 1200W2
• Catalog Number: 1200W2-D-04U-02
• Company DUNS: 341318999
• Company Name: Norav Medical GmbH
• 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: false
• 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: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com
• Phone: +4961345679830
• Email: info@norav.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260498565054 [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: 2020-07-17
• Device Publish Date: 2020-07-09

On-Brand Devices [Norav 1200 Series PC-ECG]

• 04260498566839: PC-ECG, LO, Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings wi
• 04260498566822: PC-ECG, LO, Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings wi
• 04260498566815: PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with EC
• 04260498566808: Kit includes: PC-ECG 1200HRT (UDI: 04260498566815) for High Resolution Resting-ECG and Stress-Te
• 04260498566846: PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with EC
• 04260498566853: Kit includes: PC-ECG 1200HRT (UDI: 04260498566815) for High Resolution Resting-ECG and Stress-Te
• 04260498566990: ECG Leadwire Set for 1200W with a Length of 1000mm, Clip connectors, AHA color coding
• 04260498566983: ECG Leadwire Set for 1200W with a Length of 1000mm, Clip connectors, IEC color coding
• 04260498566976: ECG Leadwire Set for 1200W with a Length of 1000mm, Snap connectors, IEC color coding
• 04260498566969: ECG Leadwire Set for 1200W with a Length of 1000mm, Snap connectors, AHA color coding
• 04260498566952: Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.02), GE-Service
• 04260498566938: Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02), GE-Service
• 04260498566921: Kit includes: PC-ECG 1200W (UDI: 04260498565054) wireless Stress-Test Kit (Rev.02)
• 04260498566914: Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02)
• 04260498566907: Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output.
• 04260498566877: Kit includes: PC-ECG 1200HR (UDI: 04260498566822) for High Resolution Resting-ECG and Stress-Tes
• 04260498565054: PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling; Special edition
• 04260498565047: PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labelling; Special edition
• 04260498564057: 12 Lead ECG Cable with D15 type plug and Clip electrode connectors and build-in 10kOhm resistor