F&P Optiflow
F&P Optiflow Air/Oxygen Flow Source supplies high-flow respiratory gas in hospital settings. The operator selects the flow and oxygen concentration, with a range up to 70 liters per minute…
F&P Optiflow Air/Oxygen Flow Source supplies high-flow respiratory gas in hospital settings. The operator selects the flow and oxygen concentration, with a range up to 70 liters per minute and 21 to 100 percent oxygen.
The device uses room air and an external oxygen supply. A touchscreen provides controls and displays the delivered flow and oxygen concentration, with audible and visual alarms for specified conditions.
Listed Item
F&P Optiflow Air/Oxygen Flow Source
Therapy Role
The flow source is a reusable, multipatient device supplied nonsterile for use by qualified healthcare professionals. It delivers respiratory gas within its stated specifications and is not intended for life support, apneic ventilation or patients with bypassed upper airways.
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 | Fisher & Paykel Healthcare, Ltd., New Zealand |
|---|---|
| FDA product code | BZR |
| Device type | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5330 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K243917 |
| Record published | 2025-10-29 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 50 °C; Storage environment humidity 15 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AA600US | 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 |
|---|---|
| K243917 | 2025-07-14 |
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.