F&P OptiNIV
F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size B
8manufacturers in China registered for this device type
6catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Fisher & Paykel Healthcare, Ltd., New Zealand |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-12-06 |
| Record revised | 2026-06-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -10 to 50 °C; Storage environment temperature 14 to 122 °F |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ONIV117B-F | B | In distribution |
| ONIV117B | B | In distribution |
| ONIV117C-F | C | In distribution |
| ONIV117A-F | A | In distribution |
| ONIV117A | A | In distribution |
| ONIV117C | C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252173 | 2025-09-10 |
| K203449 | 2021-04-14 |
| K083122 | 2009-03-04 |
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.