Rondex CPR Pocket Rescue Mask (Made in USA) #9140
The Rondex CPR Pocket Rescue Mask, Model #9140, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to…
The Rondex CPR Pocket Rescue Mask, Model #9140, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to help isolate the patient’s breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA
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 | Rondex Products, Inc., United States |
|---|---|
| FDA product code | CBP |
| Device type | Valve, Non-Rebreathing |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5870 |
| 510(k) | K943761 |
| Record published | 2016-11-26 |
| Record revised | 2020-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 36 to 104 °F |
| Distribution end date | 2020-07-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9140 (packaged in clamshell case) | Withdrawn |
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 |
|---|---|
| K981169 | 1998-05-19 |
| K942671 | 1995-02-07 |
| K943761 | 1994-11-10 |
| K914195 | 1991-11-08 |
| K902299 | 1990-10-26 |
| K881931 | 1988-07-21 |
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.