Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

053891128391

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

d83e3a61-a7f0-4726-9c52-239088944fe9

Public Version Date

September 02, 2019

Public Version Number

1

DI Record Publish Date

August 23, 2019

Package DI Number

20053891128395

Quantity per Package

2

Contains DI Package

00053891128391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-