JO H2O - Pineapple - Lubricant 4 floz / 120 mL - Water-Based Personal Lubricant - CC Wellness LLC

Duns Number:067692292

Device Description: Water-Based Personal Lubricant

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More Product Details

Catalog Number

-

Brand Name

JO H2O - Pineapple - Lubricant 4 floz / 120 mL

Version/Model Number

40172

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

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

-

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

21cd7b96-83e2-419a-a938-34eccd5d37a1

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Additional Identifiers

Package DI Number

20796494000612

Quantity per Package

12

Contains DI Package

00796494000618

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CC WELLNESS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 199