RONDEX CPR ISO-SHIELD
RONDEX PRODUCTS, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1419464 | 1419464 | RONDEX PRODUCTS, INC. | 1 | N | 2020-04-25 | 324 N GARDINER AVE Rockford IL US 61107 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00634376095577 | RONDEX CPR ISO-SHIELD (Made in USA) w Key Ring/Belt Loop Case & Gloves - "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 MADE IN USA" | 815-226-0452 | gene@rondex.com |
| 00634376098073 | RONDEX CPR REDI-SHIELD (Made in USA) in poly bag and gloves - "The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6"" X 6"") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve 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 ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2"" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. 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. REDI-SHIELD(TM) of Rondex MADE IN USA." | 815-226-0452 | gene@rondex.com |
| 00634376098509 | RONDEX CPR REDI-SHIELD (Made in USA) with key ring case - "The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Barrier surface area (6"" X 6"") helps isolate the rescuer from the patient. The barrier material is attached to a short bite block containing one (1) silicone valve 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 ventilation much easier when doing the head tilt/chin lift procedure. The short bite block, 1/2"" in length, reduces the risk of pushing the patient's tongue back and does not require a prescription. The REDI-SHIELD with a bite block advantage is very compact and is ideal for unitized packaging in first aid kits and key ring cases. 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. REDI-SHIELD(TM) of Rondex MADE IN USA." | 815-226-0452 | gene@rondex.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 73009 | 1310424382 | K981169 | RONDEX CPR ISO-SHIELD | CBP | 1998-05-19 |
| 73009 | 1272071421 | K943761 | NON-BREATHING VALVE | CBP | 1994-11-10 |
| 73009 | 1780587075 | K942671 | CPR SHIELD | CBP | 1995-02-07 |
| 73009 | 1402971617 | K914196 | RONDEX MASKS MODELS 9015/9011/901102 MODIFIED | BTM | 1991-11-08 |
| 73009 | 1284405450 | K902299 | CPR VALVE (NON-REBREATHING) MODEL #9030 | CBP | 1990-10-26 |
| 73009 | 1175459021 | K902298 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS | BSJ | 1990-08-22 |
| 73009 | 1201270517 | K881931 | RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR | CBP | 1988-07-21 |
| 73009 | 1287209249 | K881393 | RONDEX RESCUE MASK | BSJ | 1988-04-25 |
| 73009 | 1572416335 | K855218 | RONDEX CPR VALVE | CBP | 1986-02-12 |
| 73009 | 1175250407 | K834250 | RESCUE MASK | BTM | 1984-01-18 |
| 73009 | 1818416204 | K760941 | MASK ARTIFICIAL RESPIRATION | BYG | 1977-01-12 |
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
RONDEX PRODUCTS, INC.
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