ARES620 Secure Sleep Test Accessories – 10 Pack
ARES 620 CoC Disposables - (all disposables plus CoC shield) x10
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Watermark Medical Inc, United States |
|---|---|
| FDA product code | NFB |
| Device type | Conserver, Oxygen |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K160499 |
| Record published | 2017-05-19 |
| Record revised | 2023-12-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Special storage condition: Keep Dry; Storage environment temperature 15 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 620 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conserver, Oxygen | Salter Labs | 23 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 20 |
| AirLife™ | Airlife, Inc. | 17 |
| AirLife™ | Vyaire Medical, Inc. | 13 |
| Evolution | Inovo Inc. | 11 |
| Bonsai | Inovo Inc. | 9 |
| drive | Drive DeVilbiss Healthcare | 7 |
| Economizer Conserving Regulator | Inovo Inc. | 4 |
| Oxymizer | Inovo Inc. | 3 |
| Medline | Medline Industries, Inc. | 2 |
| Drive | Inovo Inc. | 2 |
| AirLife | Carefusion | 2 |
Showing 12 of 29. All products under Conserver, Oxygen
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.