Catalog Number

-

Brand Name

Honeywell

Version/Model Number

HCM-350B

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

6947a3a0-6879-40f8-b205-ad0cdc32cf7e

Public Version Date

May 27, 2020

Public Version Number

3

DI Record Publish Date

November 03, 2017

Package DI Number

70092926203503

Quantity per Package

2

Contains DI Package

00092926203504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case