| Primary Device ID | 00858522003227 |
| NIH Device Record Key | 91e1895c-2765-43bb-bc1b-76feb0e6b7b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZQuiet S.A. |
| Version Model Number | ZQSA-XM |
| Company DUNS | 020904101 |
| Company Name | SLEEPING WELL, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858522003227 [Primary] |
| LRK | Device, Anti-Snoring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00858522003289 | Contains 3 of each of the following packaged assemblies: ZQuiet S.A. Dental Size A Single Unit - |
| 00858522003265 | ZQuiet S.A. Dental Size D Single Unit |
| 00858522003258 | ZQuiet S.A. Dental Size C Single Unit |
| 00858522003241 | ZQuiet S.A. Dental Size B Single Unit |
| 00858522003234 | ZQuiet S.A. Dental Size A Single Unit |
| 00858522003227 | Oral Appliance System for Snoring and Obstructive Sleep Apnea Pack contains: (1) Size A mouthpie |