RONDEX CPR REDI-SHIELD (Made in USA) poly bag

FDA UDI

by Rondex Products, Incorporated

Identity

Trade Name: RONDEX CPR REDI-SHIELD (Made in USA) poly bag 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 MADE IN USA FDA UDI
Model / Reference: 9800 (packaged in poly bag) 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 MADE IN USA FDA UDI

Identifiers

Catalog Number: 9800 FDA UDI
Primary DI / UDI-DI: 00634376098004 FDA UDI
510(k) Number: K981169 FDA UDI
FDA Product Code: LYM FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary resuscitation mask, single-use

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

Similar devices

Also classified as Cardiopulmonary resuscitation mask, single-use.

16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class II
First Aid Only — Acme United Corporation · Class I
10PW - Oklahoma Gas & Electric - Poly White — Certified Safety Manufacturing, Inc. · N
MedSource Emergency Pocket Care Mask, w/o O2 port, Hard Case — MEDSOURCE INTERNATIONAL LLC · Class II
Rescue Breather — O-Two Medical Technologies Inc · Class I
EMT - Duke Energy TD - Red Bag — Certified Safety Manufacturing, Inc. · Class II
ZLB - 10 - Metra 49-980170 — Certified Safety Manufacturing, Inc. · Class II

Cleared under the same submission

K981169 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Rondex Products, Incorporated

Sources (1)

FDA UDI 8d72c96e-a02b-41b6-84de-e939378da343 36 fields · synced May 30, 2026