Catalog Number

4000-PEEP

Brand Name

Disposable PEEP Valve

Version/Model Number

4000-PEEP

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

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

K981415,K981415,K981415

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

fc3be768-2261-4677-bfae-636bf84b2e14

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

B0024000PEEP3

Quantity per Package

12

Contains DI Package

B0024000PEEP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 12