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Rondex CPR ISO-SHIELD (Made in USA) w poly bag

FDA UDI

by Rondex Products, Incorporated

Identity

Trade Name
Rondex CPR ISO-SHIELD (Made in USA) w poly bag FDA UDI
Generic Name
Cardiopulmonary resuscitation mask, single-use FDA UDI
Device Name
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 FDA UDI
Model / Reference
9500 (packaged in poly bag) FDA UDI
Description
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 FDA UDI

Identifiers

Catalog Number
9500 FDA UDI
Primary DI / UDI-DI
00634376095003 FDA UDI
510(k) Number
K942671 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary resuscitation mask, single-use

Rondex CPR ISO-SHIELD (Made in USA) w 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.

Cleared under the same submission

K942671 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rondex Products, Incorporated

Sources (1)

  • FDA UDI 073b003a-3a4d-4431-b985-125ba31019c8 37 fields · synced May 30, 2026