O-Two
O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both…
O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear PVC facemask is ideal for use where disinfection after use is normally undertaken by cold chemical sterilant.The universal mask 02FM4999 fits patients from Adult to infant.
Who Else Makes It
Concentrated in Zhejiang (27), Guangdong (16), Jiangsu (8). 17 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 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Xiantao Sanda Industrial Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 71. All 71 manufacturers in China registered for Mask, Gas, Anesthetic
Record
| Listed by | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | BSJ |
| Device type | Mask, Gas, Anesthetic |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5550 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-10-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02FM5000 | In distribution | |
| 02FM5097 | In distribution | |
| 02FM4999 | In distribution | |
| 02FM5210 | In distribution | |
| 02FM5102 | In distribution | |
| 02FM5205 | In distribution | |
| 02FM5203 | In distribution | |
| 02FM5101 | In distribution | |
| 02FM5099 | In distribution | |
| 02FM5208 | In distribution | |
| 02FM5206 | In distribution | |
| 02FM5098 | In distribution | |
| 02FM5207 | In distribution | |
| 02FM5001 | In distribution | |
| 02FM5100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 205 |
| Medline | Medline Industries, Inc. | 49 |
| Rusch | Teleflex Medical LLC | 45 |
| Portex | ICU Medical, Inc | 33 |
| Compower | Xiamen Compower Medical Tech. Co., Ltd. | 29 |
| AincA® | Anesthesia Associates, Inc. | 29 |
| Hudson RCI | Teleflex Medical LLC | 27 |
| Deluxe Full Face Mask | Mercury Medical Enterprises, LLC | 27 |
| King Mask | Ambu A/S | 26 |
| Mask, Gas, Anesthetic | VBM Medizintechnik Gmbh | 23 |
| Cardinal Health | Cardinal Health 200, LLC | 23 |
| Vital Signs™ | Airlife, Inc. | 19 |
Showing 12 of 270. All products under Mask, Gas, Anesthetic
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.