Catalog Number

K618-018

Brand Name

36M - Class B Select - Metal

Version/Model Number

K618-018

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

057267d0-41c2-4a45-ac2c-5ba4f3306cb5

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-