Conserver, Oxygen
Demand Nasal Cannula (pediatric) with 7' (2.1 m) O2 supply tube, for use with Dual Port Demand Valve
1manufacturer
23catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Salter Labs, United States |
|---|---|
| FDA product code | NFB |
| Device type | Conserver, Oxygen |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151506 |
| Record published | 2017-07-28 |
| Record revised | 2022-03-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature -40 to 60 °C |
| Packaging | Pack of 25, pack of 10, pack of 300, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SO-2053 | Adult | In distribution |
| SO-2054 | Adult | In distribution |
| 4807-7-7 | Adult | In distribution |
| SO-1302 | Adult | In distribution |
| 4907-7-7 | Adult | In distribution |
| 4904-4-4 | Adult | In distribution |
| 4804TLC-4-4 | Adult | In distribution |
| M041618 | Adult | In distribution |
| 4824-4-4 | Pediatric | In distribution |
| M838152-0 | adult | In distribution |
| SO-405-0 | In distribution | |
| 4805-5-5 | Adult | In distribution |
| SO-1314 | Adult | In distribution |
| 4807TLC-7-7 | Adult | In distribution |
| SO-2012 | Adult | In distribution |
| 4805TLC-5-5 | Adult | In distribution |
| 4905-5-5 | Adult | In distribution |
| 4827-7-7 | Pediatric | In distribution |
| SO-1971 | Adult | In distribution |
| SO-1964 | Adult | In distribution |
| SO-426-14-14-25 | Adult | In distribution |
| M840514-0 | Pediatric | In distribution |
| SO-404 | Adult | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 2 |
Showing 12 of 29. All products under Conserver, Oxygen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151506 | 2016-03-11 |
| K990678 | 1999-05-07 |
| K892407 | 1989-07-24 |
| K890298 | 1989-02-23 |
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.