Catalog Number

-

Brand Name

LCD

Version/Model Number

022H73

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

K963924,K963924

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

c0dd1cce-f634-4a93-be76-07a9204ab679

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2016

Package DI Number

00744229220237

Quantity per Package

50

Contains DI Package

00744229220220

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton