Catalog Number

-

Brand Name

eMist

Version/Model Number

EM100A

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

K081738,K081738

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

309eb855-10b6-45d7-889a-189172e39c4a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 04, 2017

Package DI Number

14719872486036

Quantity per Package

20

Contains DI Package

04719872486039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-