RONDEX CPR REDI-SHIELD (Made in USA) in key ring case

FDA UDI

by Rondex Products, Incorporated

Identity

Trade Name: RONDEX CPR REDI-SHIELD (Made in USA) in key ring case FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name: 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 Products, Inc. MADE IN USA. FDA UDI
Model / Reference: 9850 (packaged in key ring case) FDA UDI
Description: 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 Products, Inc. MADE IN USA. FDA UDI

Identifiers

Catalog Number: 9850 FDA UDI
Primary DI / UDI-DI: 06343760098509 FDA UDI
FDA Product Code: LYM FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

Yes

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

Yes

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Convenience Kit

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Combination Product

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HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

RONDEX CPR REDI-SHIELD (Made in USA) in key ring case by Rondex Products, Incorporated — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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Manufacturer

Manufacturer: Rondex Products, Incorporated

Sources (1)

FDA UDI 56b48241-fec5-45a3-a030-32e2cb863869 36 fields · synced May 30, 2026