Catalog Number

-

Brand Name

UnoMist™ Nebulizer Mask Kit

Version/Model Number

3776-E

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

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

57db99ec-213d-4dc7-8772-c0c02680eeda

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 23, 2016

Package DI Number

10709078001946

Quantity per Package

50

Contains DI Package

00709078001949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-