AirLife™
AirLife™ Pediatric Dual Dial Venturi Style Mask With 6 inch (15 cm) Flextube, Color Coded Low and Medium Concentration Dials, High Humidity Adapter / Humidification Hood, 7 foot (2.1 m)…
AirLife™ Pediatric Dual Dial Venturi Style Mask With 6 inch (15 cm) Flextube, Color Coded Low and Medium Concentration Dials, High Humidity Adapter / Humidification Hood, 7 foot (2.1 m) Crush Resistant Oxygen Tubing and U/Connect-It Adapter
Who Else Makes It
Concentrated in Zhejiang (40), Guangdong (29), Jiangsu (23). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Evereast Medical Products Group Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
Showing 12 of 126. All 126 manufacturers in China registered for Mask, Oxygen
Record
| Listed by | Airlife, Inc., United States |
|---|---|
| FDA product code | BYG |
| Device type | Mask, Oxygen |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5580 |
| Premarket notification | Exempt |
| Record published | 2025-03-06 |
| Record revised | 2025-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 50 °C |
| Packaging | Case of 50, case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001205U | In distribution | |
| 001259U | In distribution | |
| 001260 | In distribution | |
| 001265U | In distribution | |
| 001212U | In distribution | |
| 001260U | In distribution | |
| 001250U | In distribution | |
| 001267U | In distribution | |
| 001247U | In distribution | |
| 001262U | In distribution | |
| 001202 | In distribution | |
| AM-1200 | In distribution | |
| 001206 | In distribution | |
| 001269UC | In distribution | |
| 001204 | In distribution | |
| AM-1100 | In distribution | |
| 001201 | In distribution | |
| 001210U | In distribution | |
| AM-1000 | In distribution | |
| 001268U | In distribution | |
| 001255U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 87 |
| Mask, Oxygen | Salter Labs | 61 |
| Curaplex | TRI-Anim Health Services, Inc. | 34 |
| 7301 EAGLE1 | Hans Rudolph, Inc. | 33 |
| Curaplex | Bound Tree Medical, LLC | 33 |
| Roscoe | Drive DeVilbiss Healthcare | 32 |
| BF | Allied Medical LLC | 28 |
| Ventlab | Ventlab, LLC | 25 |
| Adsafe™ | American Diagnostic Corp. | 25 |
| 7302 EAGLE2 | Hans Rudolph, Inc. | 24 |
| Oxygen Mask | Well Lead Medical Co., Ltd. | 24 |
| Procure | Twin Med, LLC | 19 |
Showing 12 of 302. All products under Mask, Oxygen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K811711 | 1981-07-01 |
| K802323 | 1980-10-03 |
| K790166 | 1979-03-16 |
| K790163 | 1979-02-16 |
| K790165 | 1979-02-06 |
| K790164 | 1979-02-06 |
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.