(Health & Safety Institude) HSI CPR ISO-Shield (Made in USA) With Key Ring Case
The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5…
The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7″ X 7″ (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves which helps to isolate the patient’s breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient’s mouth open. This makes ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient’s tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient’s face between resuscitation breaths. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex Products, Inc. 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) | K942671 |
| Record published | 2023-05-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Handling environment temperature -40 to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Model 9550 | In distribution | |
| Model 9550-G | 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 |
|---|---|
| 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.