MaxBlend Lite, Low Flow, 30LPM
MaxBlend Lite combines oxygen monitoring and flow control for continuous delivery of an air and oxygen mixture to infant, pediatric and adult patients. Its low-flow blender configuration…
MaxBlend Lite combines oxygen monitoring and flow control for continuous delivery of an air and oxygen mixture to infant, pediatric and adult patients. Its low-flow blender configuration has a range of 0 to 30 litres per minute. Trained healthcare personnel use it under a physician’s direction in hospitals, sub-acute facilities and nursing-care settings.
The blender mixes medical air and oxygen, while an adjustable flowmeter controls delivery. A battery-powered oxygen monitor measures the concentration in the blended gas, displays the result and provides user-set high and low oxygen alarms. It is not intended to provide life support.
Modular Assembly
The monitor and flowmeter module can be supplied with a blender already attached or installed on an existing compatible blender. The flowmeter range must match the blender’s range.
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 | 2018-01-02 |
| Record revised | 2019-01-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R229P03-003 | In distribution |
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 |
| MaxFlo2 | Maxtec, LLC | 11 |
| MicroMax | Maxtec, LLC | 9 |
| Bird™ | Vyaire Medical, Inc. | 8 |
| Gentec® | Gentec (Shanghai) Corporation | 8 |
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.