Maxblend 2
The MaxBlend 2 supplies a continuous mixture of medical air and oxygen and monitors the oxygen concentration being delivered. It is intended for infants, children and adults in professional…
The MaxBlend 2 supplies a continuous mixture of medical air and oxygen and monitors the oxygen concentration being delivered. It is intended for infants, children and adults in professional healthcare settings, operated by trained personnel under a physician’s direction.
The unit combines an enclosed air/oxygen blender, an adjustable flowmeter and a battery-powered oxygen monitor. The blender mixes the gases, the flowmeter controls delivery rate and the monitor displays the measured oxygen concentration.
Listed Item
MAXBLEND2, 0-15 LPM, BMD W/ Diss, 50 PSI
Oxygen Alarms
The operator can set high and low oxygen concentration alarms. The device is not intended to be life supporting, and its role is gas mixing, flow control and concentration monitoring within the connected equipment.
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 | 2016-12-05 |
| Record revised | 2019-05-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2019-05-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R229P01-011 | In distribution | |
| R229P01-010 | In distribution | |
| R229P01-012 | Withdrawn | |
| R229P01-013 | Withdrawn |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 |
| 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.