Catalog Number

-

Brand Name

Honeywell

Version/Model Number

HUL565W

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)

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

cb86ab08-710e-46d6-8179-1c51c48d389f

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 16, 2021

Package DI Number

10328785006640

Quantity per Package

2

Contains DI Package

00328785006643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case