Economizer Conserving Regulator
4 catalogue numbers from IN4606-L-GREEN, listed by Inovo Inc., United States, under Conserver, Oxygen. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue 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 |
| Record published | 2016-11-11 |
| Record revised | 2023-02-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2021-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IN4606-L-GREEN | Withdrawn | |
| IN4606-L-BLUE-SALTER | Withdrawn | |
| IN4606-L-GREEN-SALTER | Withdrawn | |
| IN4606-L-BLUE | Withdrawn |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 |
| Bonsai | Inovo Inc. | 9 |
| drive | Drive DeVilbiss Healthcare | 7 |
| 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.