MAXBLEND2
The FDA filing names MaxBlend 2 as a subject device in the MaxBlend family. The blender combines medical air and oxygen, controls flow rate and monitors oxygen concentration.
The FDA filing names MaxBlend 2 as a subject device in the MaxBlend family.
The blender combines medical air and oxygen, controls flow rate and monitors oxygen concentration.
Listed Item
MaxBlend2 High Flow 0-70 LPM Flowmeter DISS Fitting
Device Configuration
The filing describes MaxBlend 2 as an oxygen-delivery device that combines an air/oxygen blender, battery-powered oxygen monitor and adjustable flowmeter in one assembly. The family is designed to provide a continuous air/oxygen mixture and monitor the oxygen concentration delivered to patients.
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) | K161718 |
| Record published | 2017-03-09 |
| Record revised | 2019-01-14 (version 4) |
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, manufacturing date, serial number |
| Distribution end date | 2019-05-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R229P01-004 | In distribution | |
| R229P01-031 | In distribution | |
| High Flow | In distribution | |
| R229P02-007 | In distribution | |
| R229P01-020 | In distribution | |
| R229P02-001 | In distribution | |
| R229P01-030 | In distribution | |
| R229P01-007 | In distribution | |
| R229P01-028 | In distribution | |
| R229P01-027 | In distribution | |
| High Flow | In distribution | |
| R229P01-001 | In distribution | |
| R229P01-025 | In distribution | |
| R229P01-024 | In distribution | |
| R229P02-004 | In distribution | |
| R229P02-002 | Withdrawn | |
| R229P01-002 | Withdrawn |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 |
| 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
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.