Blender
MICBLNDR,.15-1.0/1.0-10.0 Lpm,diss,ce,lo
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 | Carefusion, United States |
|---|---|
| FDA product code | BZR |
| Device type | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5330 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K883038 |
| Record published | 2015-10-24 |
| Record revised | 2024-12-11 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10501 | Withdrawn | |
| 10040A | Withdrawn | |
| 10046A | Withdrawn | |
| 10047A | Withdrawn | |
| 11930 | Withdrawn | |
| 10042A | Withdrawn | |
| 10041A | Withdrawn | |
| 11391-PMN | Withdrawn | |
| 10071A | Withdrawn | |
| 10352 | Withdrawn | |
| 10048A | Withdrawn | |
| 10160 | Withdrawn | |
| 03800A | Withdrawn | |
| 10049A | Withdrawn | |
| 10030A | Withdrawn | |
| 11322 | Withdrawn | |
| 16694 | Withdrawn | |
| 10160A | Withdrawn | |
| 03803T | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 43 |
| Hyperinflation | Westmed, Inc. | 21 |
| 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.