Hyperinflation
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Neonatal Mask
2manufacturers in China registered for this device type
21catalogue 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 | Westmed, Inc., United States |
|---|---|
| FDA product code | BZR |
| Device type | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5330 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K932709 |
| Record published | 2015-10-24 |
| Record revised | 2025-12-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 12, pack of 20, pack of 50 |
| Distribution end date | 2026-01-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7-N7905-62 | In distribution | |
| 7-N7915-62-29I | In distribution | |
| MC79020220 | In distribution | |
| 7-N7901-MAN | In distribution | |
| 7-N7915-56I-62 | In distribution | |
| 7-N7905-N-MAN | In distribution | |
| 7-N7901-62 | In distribution | |
| 7-N7905 | In distribution | |
| 7-N7905-N | In distribution | |
| 0413 | In distribution | |
| 7-N7905-I | In distribution | |
| 7-N7910 | In distribution | |
| 7-N7905-MAN | Withdrawn | |
| 7-N7903-62 | Withdrawn | |
| 900 000 622 | Withdrawn | |
| 0414 | Withdrawn | |
| 7-N7905-I-MAN | Withdrawn | |
| 900 000 627 | Withdrawn | |
| 900 000 621 | Withdrawn | |
| 7-N7905-MAN-P | Withdrawn | |
| 7-N7902-62 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 43 |
| 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 |
| AirLife | Carefusion | 7 |
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.