Catalog Number

-

Brand Name

PS 54-1A Adapter for Exhalation Valves

Version/Model Number

PS 54-1A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

-

FDA Premarket Submission

K980725,K980725

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

a49ea774-8776-48ef-a089-b5bcd3d8bcf9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 11, 2017

Package DI Number

M996PS541A2

Quantity per Package

10

Contains DI Package

M996PS541A0

Package Discontinue Date

-

Package Status

-

Package Type

ziplock bag