MaxBlend Lite
MaxBlend Lite combines an oxygen monitor and adjustable flowmeter for use with a compatible air and oxygen blender. The system supplies a continuous gas mixture while measuring the oxygen…
MaxBlend Lite combines an oxygen monitor and adjustable flowmeter for use with a compatible air and oxygen blender. The system supplies a continuous gas mixture while measuring the oxygen concentration delivered to infant, pediatric or adult patients.
The battery powered monitor displays oxygen concentration and provides user selectable high and low oxygen alarms. The flowmeter controls delivered flow, while the blender mixes medical grade air and oxygen. The Lite module can be installed on an existing compatible blender.
Listed Item
High Flow 0-70 LPM MicroMax/Precision
Professional Use
MaxBlend Lite may be supplied with or without a preassembled blender, depending on configuration. It is intended for qualified personnel under physician direction in professional healthcare settings such as hospitals, subacute care and nursing facilities. It is not intended as a life supporting device.
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 | 2019-01-14 |
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 |
|---|---|---|
| R229P03-007 | In distribution | |
| R229P03-006 | In distribution | |
| R229P03-005 | In distribution | |
| R229P03-008 | 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.