Teleflex/Hudson RCI
.5 Ltr. Hyperinflation Bag System
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Gentec (Shanghai) Corporation | Shanghai | Shanghai | Manufacturer | 12 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | BZR |
| Device type | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5330 |
| Record published | 2016-04-08 |
| Record revised | 2026-06-08 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 20 |
| Sizes | Total volume 0.5 to 1 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5402 | Total Volume 0.5 l | In distribution |
| 5403 | liter per bag | In distribution |
| 5401 | Total Volume 0.5 l | In distribution |
| 5404 | Total Volume 1 l | In distribution |
| 2700-205 | Total Volume 0.5 l | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 43 |
| Hyperinflation | Westmed, Inc. | 21 |
| Blender | Carefusion | 19 |
| Hyperinflation (Ambu) | Westmed, Inc. | 19 |
| MAXBLEND2 | Maxtec, LLC | 17 |
| Blender | Vyaire Medical, Inc. | 17 |
| Ambu Hyperinflation System | Westmed, Inc. | 12 |
| Ambu | SunMed Group Holdings, LLC | 12 |
| MaxFlo2 | Maxtec, LLC | 11 |
| MicroMax | Maxtec, LLC | 9 |
| Bird™ | Vyaire Medical, Inc. | 8 |
| Gentec® | Gentec (Shanghai) Corporation | 8 |
Showing 12 of 118. All products under Mixer, Breathing Gases, Anesthesia Inhalation
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.