Catalog Number

CF9003

Brand Name

Evo Medical Comfort PAP, CareFusion PureSom, and ProBasics Zzz-Pap Style

Version/Model Number

CF9003

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JRL

Product Code Name

Unit, Filter, Membrane

Public Device Record Key

7befc8ea-7675-4dc6-87b9-48f29a3258bc

Public Version Date

July 05, 2018

Public Version Number

1

DI Record Publish Date

June 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-