DeVilbiss
Respiratory Conservers Product Description REBUILT PD1000A W/M6 CYL
1manufacturer
20catalogue numbers in this listing
2recalls on this 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 | DeVilbiss Healthcare LLC., United States |
|---|---|
| FDA product code | NFB |
| Device type | Conserver, Oxygen |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2020-04-03 |
| Record revised | 2024-01-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C |
| Distribution end date | 2024-01-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PD1000A-ML6-RE | Withdrawn | |
| PD1000A-E | Withdrawn | |
| PD1000A-CAN-C | Withdrawn | |
| PD1000A-CAN-D | Withdrawn | |
| PD1000 | Withdrawn | |
| PD1000A-CAN-E | Withdrawn | |
| PD1000G | Withdrawn | |
| PD1000A-D | Withdrawn | |
| PD1000A-I-C | Withdrawn | |
| PD1000A-M6 | Withdrawn | |
| PD1000I | Withdrawn | |
| PD1000A-I-E | Withdrawn | |
| PD1000A-CAN-M4 | Withdrawn | |
| PD1000A-I-ML6 | Withdrawn | |
| PD1000A-ML6 | Withdrawn | |
| PD1000A-C | Withdrawn | |
| PD1000A-I-D | Withdrawn | |
| PD1000A-M4 | Withdrawn | |
| PD1000A-M6-RE | Withdrawn | |
| PD1000D-607 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conserver, Oxygen | Salter Labs | 23 |
| 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
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-01-24 | Not classified | Other | Cylinder could lose oxygen at high pressure after the filling process | 4,169 units (Z-0731/0732-2007) | 2009-08-27 |
| 2007-01-24 | Not classified | Other | Cylinder could lose oxygen at high pressure after the filling process | 4,169 units (Z-0731/0732-2007) | 2009-08-27 |
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.