| Primary Device ID | 00869770000234 |
| NIH Device Record Key | d24a589c-828f-4dc6-8360-4fbe2cff7866 |
| Commercial Distribution Discontinuation | 2017-05-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ZIO SR Patch |
| Version Model Number | K100A101X |
| Company DUNS | 861237670 |
| Company Name | IRHYTHM TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869770000234 [Primary] |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-09-19 |
| 00850043907046 - Zio ECG Utilization Software (ZEUS) System | 2024-08-05 |
| 00869770000241 - Zio monitor | 2022-05-11 |
| 00869770000210 - ZIO AT Patch | 2019-11-08 ZIO AT ECG Monitoring Service |
| 00869770000203 - ZIO XT Patch | 2019-11-08 ZIO XT ECG Monitoring Service |
| 00869770000234 - ZIO SR Patch | 2019-11-08ZIO SR ECG Monitoring Service |
| 00869770000234 - ZIO SR Patch | 2019-11-08 ZIO SR ECG Monitoring Service |