HEALTH & SAFETY INSTITUTE (HSI) CPR REDI-SHIELD (Made in USA)

FDA UDI

by Rondex Products, Incorporated

Identity

Trade Name: HEALTH & SAFETY INSTITUTE (HSI) CPR REDI-SHIELD (Made in USA) FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name: The HSI CPR REDI-SHIELD model #9850-G comes in a zipper case with a key ring and gloves. It 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. 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. FDA UDI
Model / Reference: 9850-G FDA UDI
Description: The HSI CPR REDI-SHIELD model #9850-G comes in a zipper case with a key ring and gloves. It 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. 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 06343760498576 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

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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

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HEALTH & SAFETY INSTITUTE (HSI) CPR REDI-SHIELD (Made in USA) 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 764082e3-1ac4-4ae1-8138-d1328c4d41f4 35 fields · synced Jun 8, 2026