Bonsai
INT-812 Conserver With ML6 Oxygen Cylinder
1manufacturer
9catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Inovo Inc., United States |
|---|---|
| FDA product code | NFB |
| Device type | Conserver, Oxygen |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K070740 |
| Record published | 2016-11-11 |
| Record revised | 2023-12-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
| Packaging | Master carton of 24 |
| Distribution end date | 2023-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM-824 | In distribution | |
| INT-812ML6 | In distribution | |
| OM-812CE | In distribution | |
| OM-812 | In distribution | |
| INT-812M6 | In distribution | |
| INT-812M9 | In distribution | |
| OM-810CE | Withdrawn | |
| OM-810 | Withdrawn | |
| INT-812D | Withdrawn |
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 |
| 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 |
|---|---|
| K113111 | 2011-12-08 |
| K103392 | 2010-12-17 |
| K060751 | 2006-07-18 |
| K051540 | 2005-09-21 |
| K031983 | 2003-09-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-04-26 | Class II | Process control | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. | 690 | 2021-04-02 |
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.