CPR Rescue Mask Kit
Catalogue number 4924, listed by Dynarex Corp., United States, under Valve, Non-Rebreathing. 19 manufacturers in China are registered for this product code.
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 | Dynarex Corp., United States |
|---|---|
| FDA product code | CBP |
| Device type | Valve, Non-Rebreathing |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5870 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-10-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4924 | 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 |
| WNL product | Xiamen Compower Medical Tech. Co., Ltd. | 6 |
| Kemp USA | Foremount Enterprise Co., Ltd. | 6 |
| 2700 Nrbv | Hans Rudolph, Inc. | 5 |
Showing 12 of 231. All products under Valve, Non-Rebreathing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K052743 | 2005-12-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-07-02 | Class II | Employee error | “THIS SIDE UP” is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers. | Domestic: 208 cases; Foreign: 42 cases | 2017-04-20 |
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.