| Primary Device ID | 04260498564309 |
| NIH Device Record Key | 4f81378a-5e44-4e37-9b97-b26854ce42b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Norav |
| Version Model Number | C3-C-U-ODU |
| Catalog Number | C3-C-U-ODU |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com | |
| Phone | +4961345679830 |
| info@norav.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260498564309 [Primary] |
| IKD | Cable, Electrode |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2018-09-18 |
| 04260498564057 - Norav 1200 Series PC-ECG | 2023-02-27 12 Lead ECG Cable with D15 type plug and Clip electrode connectors and build-in 10kOhm resistor |
| 04260498565047 - Norav 1200 Series PC-ECG | 2020-07-17 PC-ECG Wireless Acquisition Device for Stress-Test ECG with IEC type labelling; Special edition for GE Health Care. |
| 04260498565054 - Norav 1200 Series PC-ECG | 2020-07-17 PC-ECG Wireless Acquisition Device for Stress-Test ECG with AHA type labelling; Special edition for GE Health Care. |
| 04260498565283 - Norav NR Series | 2020-07-17 Norav Telemetry ECG Acquisition Device NR-314-T for Telemetry 3 Channel Resting-ECG Monitoring with AHA type labelling. |
| 04260498566860 - Norav NR Series | 2020-07-17 Kit includes: Norav Telemetry ECG Recording Unit NR-314-T (UDI: 04260498565283) for 3 Channel ECG Telemetry with AHA type labell |
| 04260498566877 - Norav 1200 Series PC-ECG | 2020-07-17 Kit includes: PC-ECG 1200HR (UDI: 04260498566822) for High Resolution Resting-ECG and Stress-Test ECG recordings with IEC type l |
| 04260498566907 - Norav 1200 Series PC-ECG | 2020-07-17 Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output. |
| 04260498566914 - Norav 1200 Series PC-ECG | 2020-07-17 Kit includes: PC-ECG 1200W (UDI: 04260498565047) wireless Stress-Test Kit (Rev.02); PC-ECG 1200WR (UDI: 042 |