Rondex CPR ISO-SHIELD (Made In USA) w poly bag & gloves - The Rondex CPR ISO-SHIELD is a mouth-to-mask - RONDEX PRODUCTS, INCORPORATED

Duns Number:021435706

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

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

9500-G

Brand Name

Rondex CPR ISO-SHIELD (Made In USA) w poly bag & gloves

Version/Model Number

9500-G (packaged in poly bag w gloves

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

K942671

Product Code Details

Product Code

LYM

Product Code Name

Device, Cpr Assist

Device Record Status

Public Device Record Key

513cf0c6-0aea-435b-b07e-409d422b6f58

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

October 30, 2016

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