RONDEX PRODUCTS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14194641419464RONDEX PRODUCTS, INC.1N2020-04-25324 N GARDINER AVE Rockford IL US 61107

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00634376095577RONDEX 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"815-226-0452gene@rondex.com
00634376098073RONDEX 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."815-226-0452gene@rondex.com
00634376098509RONDEX 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."815-226-0452gene@rondex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
730091310424382K981169RONDEX CPR ISO-SHIELDCBP1998-05-19
730091272071421K943761NON-BREATHING VALVECBP1994-11-10
730091780587075K942671CPR SHIELDCBP1995-02-07
730091402971617K914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIEDBTM1991-11-08
730091284405450K902299CPR VALVE (NON-REBREATHING) MODEL #9030CBP1990-10-26
730091175459021K902298ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GASBSJ1990-08-22
730091201270517K881931RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPRCBP1988-07-21
730091287209249K881393RONDEX RESCUE MASKBSJ1988-04-25
730091572416335K855218RONDEX CPR VALVECBP1986-02-12
730091175250407K834250RESCUE MASKBTM1984-01-18
730091818416204K760941MASK ARTIFICIAL RESPIRATIONBYG1977-01-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CBP61998-05-19
BTM21991-11-08
BSJ21990-08-22
BYG11977-01-12

PMN#

GUDID#