Catalog Number

-

Brand Name

PROTEC

Version/Model Number

PWF813-24

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KFZ

Product Code Name

Humidifier, Non-Direct Patient Interface (Home-Use)

Public Device Record Key

280a77b5-b265-4d34-84a6-03a85f3dc606

Public Version Date

May 27, 2020

Public Version Number

2

DI Record Publish Date

September 28, 2018

Package DI Number

50328785808136

Quantity per Package

24

Contains DI Package

00328785808131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case