Catalog Number

-

Brand Name

Honeywell

Version/Model Number

HEV615W

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

cb308f24-d26d-4e44-b4eb-a0ad70c3847a

Public Version Date

May 27, 2020

Public Version Number

3

DI Record Publish Date

October 31, 2017

Package DI Number

70328785206158

Quantity per Package

1

Contains DI Package

00328785206159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE