RespondER Emergency Rescue CPR Mask With Oxygen Port in Clam Shell
RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an integral/removable non-rebreathing valve which serves as a physical barrier for rescuers providing…
RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an integral/removable non-rebreathing valve which serves as a physical barrier for rescuers providing immediate life support to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
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 | Allied Healthcare Products, Inc., United States |
|---|---|
| FDA product code | CBP |
| Device type | Valve, Non-Rebreathing |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5870 |
| Premarket notification | Exempt |
| Record published | 2017-06-03 |
| Record revised | 2018-03-29 (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, manufacturing date |
| Packaging | Case of 100, case of 150 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMP0826 | In distribution | |
| AMP0825 | 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
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.