MaxFlo2
High Flow with MaxO2+, DISS Fitting Kit
2manufacturers in China registered for this device type
11catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Maxtec, LLC, United States |
|---|---|
| FDA product code | BZR |
| Device type | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5330 |
| 510(k) | K113232 |
| Record published | 2019-01-14 |
| Record revised | 2019-05-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH |
| Sizes | Weight 2.4 lb; depth 4.7 in; width 3.9 in; height 8.2 in |
| Distribution end date | 2019-05-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R223P08 | In distribution | |
| R223P02-007 | Withdrawn | |
| R223P02-005 | Withdrawn | |
| High Flow DISS | Weight 2.4 lb | Withdrawn |
| R223P01-006 | Withdrawn | |
| R223P02-006 | Withdrawn | |
| R223P02-003 | Withdrawn | |
| R223P01-005 | Withdrawn | |
| R223P02-004 | Withdrawn | |
| Low Flow DISS | Weight 2.4 lb | Withdrawn |
| R223P01-003 | Withdrawn |
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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231895 | 2023-12-04 |
| K161718 | 2016-10-27 |
| K113232 | 2012-03-01 |
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.