Catalog Number

199002001

Brand Name

Disposable PEEP 20 valve

Version/Model Number

199002001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Public Device Record Key

58253b6a-2cd3-407c-9725-89e6b0eb41a3

Public Version Date

June 27, 2018

Public Version Number

3

DI Record Publish Date

February 03, 2017

Package DI Number

05707480007868

Quantity per Package

240

Contains DI Package

05707480134915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-