RONDEX CPR ISO-VALVE (Made in USA) - The RONDEX CPR ISO-VALVE Model #4040 is for - RONDEX PRODUCTS, INCORPORATED

Duns Number:021435706

Device Description: The RONDEX CPR ISO-VALVE Model #4040 is for emergency used only with a suitable CPR mask The RONDEX CPR ISO-VALVE Model #4040 is for emergency used only with a suitable CPR mask. It contains a total of two (2) silicone valves to help isolate the rescuer from the patient's breath. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA (ISO-VALVE(TM) of Rondex Products, Inc.)

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


More Product Details

Catalog Number

4040

Brand Name

RONDEX CPR ISO-VALVE (Made in USA)

Version/Model Number

4040 (packaged in polybag)

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

K943761

Product Code Details

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Device Record Status

Public Device Record Key

ec344df9-9a31-462b-ac5e-4c3e9ab7e769

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

November 01, 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