Meijer Vaginal Moisturizer Personal Lubricant - Prefilled Disposable Personal Lubricant Applicator - MEIJER, INC.

Duns Number:006959555

Device Description: Prefilled Disposable Personal Lubricant Applicator

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More Product Details

Catalog Number

-

Brand Name

Meijer Vaginal Moisturizer Personal Lubricant

Version/Model Number

84010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2030

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

Yes

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

K903910

Product Code Details

Product Code

KMJ

Product Code Name

Lubricant, Patient

Device Record Status

Public Device Record Key

1dfd8ac1-ddd0-4c59-9792-6c65de3b199f

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEIJER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 45
U Unclassified 1