Catalog Number

-

Brand Name

Bubble Humidifier

Version/Model Number

0480

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

5bd8a7e6-a0a0-41a1-a1e7-f3238d67e338

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Package DI Number

10709078007603

Quantity per Package

50

Contains DI Package

00709078007606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case