Catalog Number

Disposable Adjustable PEEP Valve

Brand Name

N/A

Version/Model Number

2425

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

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

09bfe83f-8659-454b-8cbe-638e9923fe98

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

44710810080164

Quantity per Package

50

Contains DI Package

04710810080166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton