Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-3655LTF

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

K140237,K140237,K140237

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

52c670f8-86b9-4645-8379-463d43405231

Public Version Date

November 16, 2018

Public Version Number

1

DI Record Publish Date

October 16, 2018

Package DI Number

40612479231670

Quantity per Package

20

Contains DI Package

20612479231669

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case