EMS SAFETY CPR REDI-SHIELD (Made in USA) with zipper key ring case - The Rondex CPR REDI-SHIELD is a mouth-to-mask - RONDEX PRODUCTS, INCORPORATED

Duns Number:021435706

Device Description: The Rondex CPR REDI-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid 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.

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More Product Details

Catalog Number

MKRS9850Z

Brand Name

EMS SAFETY CPR REDI-SHIELD (Made in USA) with zipper key ring case

Version/Model Number

9850-Z (packaged in key ring zipper case)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 06, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LYM

Product Code Name

Device, Cpr Assist

Device Record Status

Public Device Record Key

a569650d-b82f-4518-bae6-ca97731bf443

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

July 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RONDEX PRODUCTS, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7
U Unclassified 22