Catalog Number

U22-3

Brand Name

Omron Medication Bottle

Version/Model Number

U22-3

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062263

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

19c9def3-b86c-4839-af03-0cbbc3bcd5a3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-