| Primary Device ID | 00860004541714 |
| NIH Device Record Key | a8884614-e794-4a3c-8bfe-2e023197989f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANNE Sleep |
| Version Model Number | SA-008 |
| Company DUNS | 093772547 |
| Company Name | Sibel 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004541714 [Primary] |
| MNR | Ventilatory Effort Recorder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-28 |
| Device Publish Date | 2022-07-20 |
| 00860004541714 - ANNE Sleep | 2022-07-28ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals. |
| 00860004541714 - ANNE Sleep | 2022-07-28 ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological param |
| 00860004541707 - ANNE™ One | 2021-10-28 ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electr |