Catalog Number

-

Brand Name

WaterPAP

Version/Model Number

WP-7700

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)

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

eced8ea7-befc-4c83-972d-f3fa59c90ffe

Public Version Date

November 05, 2018

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

20862146000306

Quantity per Package

4

Contains DI Package

10862146000309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case