Bio-Med Devices, Inc.
Air / Oxygen Blender low flow for International Biomedical
1manufacturer
99catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
Record
| Listed by | BIO-MED Devices, Inc., United States |
|---|---|
| FDA product code | MOD |
| Device type | Accessory To Continuous Ventilator (Respirator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K925982 |
| Record published | 2019-10-04 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2003Q | In distribution | |
| 2003EF15B | In distribution | |
| 2003EF1B | In distribution | |
| 2003FFG | In distribution | |
| 2003KC | In distribution | |
| 2003I | In distribution | |
| 2004F7015A | In distribution | |
| 2003KB | In distribution | |
| 2003FFB | In distribution | |
| 2001B | In distribution | |
| 2003FLEU | In distribution | |
| 2002 | In distribution | |
| 2003M | In distribution | |
| 2003FFEUC | In distribution | |
| 2003FFJ | In distribution | |
| 2003FFE1A | In distribution | |
| 2002F70 | In distribution | |
| 2003AJ2 | In distribution | |
| 2003GE | In distribution | |
| 2003FFAB | In distribution | |
| 2001 | In distribution | |
| 2003FFR | In distribution | |
| 20011PE | In distribution | |
| 2002K2 | In distribution | |
| 2003P | In distribution | |
| 2003FF1 | In distribution | |
| 2003KA | In distribution | |
| 2004I | In distribution | |
| 2003FFA | In distribution | |
| 2002F70B | In distribution | |
| 2003D | In distribution | |
| 2003U | In distribution | |
| 2003FFQ | In distribution | |
| 21471 | In distribution | |
| 2001KB | In distribution | |
| 2001FB | In distribution | |
| 2001K | In distribution | |
| 2003AJ1 | In distribution | |
| 2002FP70 | In distribution | |
| 2003DA | In distribution | |
| 2000KM | In distribution | |
| 2004F7015 | In distribution | |
| 2003FFE1 | In distribution | |
| 20011NPE | In distribution | |
| 2003FFH | In distribution | |
| 2003FF15B | In distribution | |
| 2002F60A | In distribution | |
| 2003FLEUX | In distribution | |
| 2003FFEU | In distribution | |
| 2003AS | In distribution | |
| 2003F | In distribution | |
| 2003FL | In distribution | |
| 2004F7015EU | In distribution | |
| 2002F70X | In distribution | |
| 2001F | In distribution | |
| 80018PE | In distribution | |
| 2003FFFP | In distribution | |
| 2003AS1 | In distribution | |
| 2003T | In distribution | |
| 2003FF15 | In distribution | |
| 2002M | In distribution | |
| 2001T | In distribution | |
| 40011PE | In distribution | |
| 2002F70A | In distribution | |
| 2000K | In distribution | |
| 2003EFB | In distribution | |
| 2003FFEA | In distribution | |
| 2003K | In distribution | |
| 2003FF | In distribution | |
| 2004F7015X | In distribution | |
| 2003J | In distribution | |
| 2003FFN | In distribution | |
| 2001M | In distribution | |
| 2003IB2 | In distribution | |
| 2003IB1 | In distribution | |
| 2003B | In distribution | |
| 2004MB | In distribution | |
| 2003FF2B | In distribution | |
| 2004B | In distribution | |
| 2003C | In distribution | |
| 2003FLB | In distribution | |
| 2003FFK | In distribution | |
| 2001MB | In distribution | |
| 2003FFEUA | In distribution | |
| 2001C | In distribution | |
| 2001FEU | In distribution | |
| 2003FFE5 | In distribution | |
| 2003AJ3 | In distribution | |
| 2004M | In distribution | |
| 2002K | In distribution | |
| 2003FLA | In distribution | |
| 2003FF1B | In distribution | |
| 2002F70D | In distribution | |
| 2003H | In distribution | |
| 2003 | In distribution | |
| 2003KJ | In distribution | |
| 2003TR | In distribution | |
| 2004 | In distribution | |
| 2003MB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Filter | Westmed, Inc. | 3 |
| HEPA Filter | Westmed, Inc. | 2 |
| CorVent® CorVision | Corvent Medical Inc. | 1 |
| Tyco-Achieva Bulk | GVS Filter Technology UK Ltd | 1 |
| CorVision with Display | Corvent Medical Inc. | 1 |
| Inogen | GVS Filter Technology UK Ltd | 1 |
| Respironics Domed (Gherkin) | GVS Filter Technology UK Ltd | 1 |
| Procure | Twin Med, LLC | 1 |
| Cart, Display Enclosure 11 inch | Corvent Medical Inc. | 1 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | UDI-DI | 2026-05-08 | Class I | Process control | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia | 550 (367 US; 183 OUS) |
| Datex-Ohmeda, Inc. | UDI-DI | 2026-05-08 | Class I | Process control | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia | 550 (367 US; 183 OUS) |
| Datex-Ohmeda, Inc. | UDI-DI | 2026-05-08 | Class I | Process control | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia | 550 (367 US; 183 OUS) |
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.