Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

053891144551

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

KFZ

Product Code Name

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

Public Device Record Key

f78ff5de-38c5-44f2-b4c2-af9fa00f4916

Public Version Date

March 26, 2020

Public Version Number

1

DI Record Publish Date

March 18, 2020

Package DI Number

30053891144552

Quantity per Package

2

Contains DI Package

00053891144551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-