ID Millennium - ID Millennium is a Silicone Based lubricant, and - WESTRIDGE LABORATORIES INCORPORATED

Duns Number:879057065

Device Description: ID Millennium is a Silicone Based lubricant, and is Latex Compatible.

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More Product Details

Catalog Number

IDDMLLGA

Brand Name

ID Millennium

Version/Model Number

Millennium 128 fl oz Pump

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141767,K141767

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

d96c11b7-4147-4cc4-979c-f01dc7ae95dc

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

January 23, 2017

Additional Identifiers

Package DI Number

10761236900898

Quantity per Package

1

Contains DI Package

00761236900891

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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