Catalog Number

-

Brand Name

WaterPAP PRO

Version/Model Number

WP-7800

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

fc62dd75-37c2-4f3a-a0ee-85d71f549c68

Public Version Date

November 05, 2018

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

40862146000300

Quantity per Package

4

Contains DI Package

30862146000303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case