Lush - A water based personal lubricant that is - WESTRIDGE LABORATORIES INCORPORATED

Duns Number:879057065

Device Description: A water based personal lubricant that is compatible with latex and polyurethane condoms.

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More Product Details

Catalog Number

-

Brand Name

Lush

Version/Model Number

Lush 17 fl oz Water Based Lubricant

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051295,K051295

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

c8213e0e-318a-48ee-8d60-b3b693f34de4

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

April 21, 2017

Additional Identifiers

Package DI Number

30864785000218

Quantity per Package

12

Contains DI Package

00864785000217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"WESTRIDGE LABORATORIES INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56