Catalog Number

-

Brand Name

Kitabis

Version/Model Number

850F0001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K935540,K935540

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

ea5db718-8b2c-4daf-b894-348c0c365c52

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 30, 2017

Package DI Number

00744229850021

Quantity per Package

4

Contains DI Package

00744229850014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton