Catalog Number

-

Brand Name

KY Warming Jelly Lubricant

Version/Model Number

Personal Lubricant

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

K040164,K040164,K040164

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

6af8e005-a0c1-46f1-9b51-48cc6d356503

Public Version Date

October 24, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

10067981089483

Quantity per Package

6

Contains DI Package

00067981089486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tube