Norav 1200 Series ECGUSB1DEX-D-00-08

GUDID 04260498564262

Single Channel ECG Acquisition Module for integration in other Medical Devices. Special edition for GE Health Care.

Norav Medical GmbH

Electrocardiographic signal amplifier

• Primary Device ID: 04260498564262
• NIH Device Record Key: 1f61a04b-de72-446d-a673-0157c48e0e45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Norav 1200 Series
• Version Model Number: ECGUSB1DEX
• Catalog Number: ECGUSB1DEX-D-00-08
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260498564262 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-12-09

On-Brand Devices [Norav 1200 Series]

• 04260498565856: Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in
• 04260498566099: Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in
• 04260498564262: Single Channel ECG Acquisition Module for integration in other Medical Devices. Special edition
• 04260498564255: Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498564262) for integration in
• 04260498566891: Single Channel ECG Acquisition Module for integration in other Medical Devices. Special edition
• 04260498566884: Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in
• 04260498567003: Kit includes: Single Channel ECG Acquisition Module (DI no.: 04260498566891) for integration in