Catalog Number

-

Brand Name

Breeze by Rexall

Version/Model Number

7W926GSC1

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

K012203,K012203,K012203

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

c22b71b7-57e6-4fb9-b29c-964c215766e4

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Package DI Number

10370030659798

Quantity per Package

6

Contains DI Package

00370030659791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner