Catalog Number

-

Brand Name

22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE 1.6M

Version/Model Number

5183000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

857abc80-6002-4a59-99cf-17485830801c

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

October 06, 2021

Package DI Number

05030267154050

Quantity per Package

20

Contains DI Package

05030267069750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-