Catalog Number

-

Brand Name

Healthline, Medicator Maximizer, Methacholine

Version/Model Number

MCT-5H

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

K960397

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

d85ac961-5c61-4f2f-80b6-ef5d34de1038

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-