Hyperinflation (Ambu)
Disposable Hyperinflation System, 1/2L Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Infant Mask
2manufacturers in China registered for this device type
19catalogue 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 | 2024-02-29 (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 |
| Packaging | Pack of 12 |
| Distribution end date | 2024-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900 000 605 | In distribution | |
| 900 000 628 | In distribution | |
| 900 000 624 | In distribution | |
| 900 000 602 | In distribution | |
| 900 000 617 | In distribution | |
| 900 000 606 | In distribution | |
| 900 000 601 | In distribution | |
| 900 000 614 | In distribution | |
| 900 000 618 | In distribution | |
| 900 000 603 | In distribution | |
| 900 000 604 | In distribution | |
| 900 000 609 | In distribution | |
| 900 000 610 | Withdrawn | |
| 900 000 626 | Withdrawn | |
| 900 000 607 | Withdrawn | |
| 900 000 623 | Withdrawn | |
| 900 000 625 | Withdrawn | |
| 900 000 612 | Withdrawn | |
| 900 000 608 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 43 |
| Hyperinflation | Westmed, Inc. | 21 |
| Blender | Carefusion | 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.