| Primary Device ID | 00850064210026 |
| NIH Device Record Key | 9e32fc5c-9501-4de2-9bd9-508109cba586 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1-Day ANNE Chest Adhesive Pouch |
| Version Model Number | 900-00014 |
| Company DUNS | 093772547 |
| Company Name | Sibel Health Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850064210026 [Primary] |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-03 |
| Device Publish Date | 2025-03-26 |
| 00850064210200 - Sibel Spacelabs Trek Chest Patch | 2025-04-10 |
| 00850064210217 - Sibel Spacelabs Trek Finger Patch | 2025-04-10 |
| 00850064210224 - Sibel Spacelabs Trek Charger | 2025-04-10 |
| 00850064210231 - Sibel Spacelabs Finger Patch Adhesive 3 day | 2025-04-10 |
| 00850064210248 - Sibel Spacelabs Trek Chest Patch Adhesive | 2025-04-10 |
| 00850064210255 - Sibel Spacelabs Trek Blood Pressure Cuff | 2025-04-10 |
| 00850064210262 - Sibel Spacelabs Trek Tablet | 2025-04-10 |
| 00860004541745 - ANNE Chest | 2025-04-10 The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activ |