WNL Product
Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, one pieces alcohol pads and one pair Nitrile glove. CPR Mask with Oxygen Port is…
Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, one pieces alcohol pads and one pair Nitrile glove. CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for Rx only and for infants with body weight up to 10kg (22 lbs).
Who Else Makes It
Concentrated in Guangdong (6), Fujian (6), Jiangsu (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Xiamen Tianzuo Medical Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 4 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Xiamen Firstcare IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Exporter | 40 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Heaven Healthcare Co., Ltd. | Shaoxing | Zhejiang | Private-label distributor | 33 |
Showing 12 of 19. All 19 manufacturers in China registered for Valve, Non-Rebreathing
Record
| Listed by | Xiamen Compower Medical Tech. Co., Ltd., China |
|---|---|
| FDA product code | CBP |
| Device type | Valve, Non-Rebreathing |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5870 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K171961 |
| Record published | 2020-03-20 |
| Record revised | 2024-04-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 100, carton of 50, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP641000 | In distribution | |
| CP646003 | In distribution | |
| CP641000+1A+NG | In distribution | |
| CP641000+1A+NG | In distribution | |
| CP641007 | In distribution | |
| CP641000+CP641007+1A+NG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valve, Non-Rebreathing | Hans Rudolph, Inc. | 139 |
| Microtek | Microtek Medical LLC | 40 |
| Curaplex | Bound Tree Medical, LLC | 39 |
| Valve, Non-Rebreathing | Intersurgical Ltd. | 17 |
| Compower | Xiamen Compower Medical Tech. Co., Ltd. | 16 |
| LSP | Allied Medical LLC | 11 |
| Top Safety | Foremount Enterprise Co., Ltd. | 10 |
| WNL | Foremount Enterprise Co., Ltd. | 10 |
| Aero US | Foremount Enterprise Co., Ltd. | 8 |
| Kemp USA | Foremount Enterprise Co., Ltd. | 6 |
| 2700 Nrbv | Hans Rudolph, Inc. | 5 |
| 2730 2WAY Nrbv | Hans Rudolph, Inc. | 4 |
Showing 12 of 231. All products under Valve, Non-Rebreathing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171961 | 2017-11-17 |
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.