Catalog Number

-

Brand Name

NA

Version/Model Number

MC-001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2020

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

cd5c2b8c-3497-4349-afee-343fedd6e20b

Public Version Date

November 03, 2020

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

10856702006027

Quantity per Package

120

Contains DI Package

00856702006020

Package Discontinue Date

November 02, 2020

Package Status

Not in Commercial Distribution

Package Type

-