JO H2O Flavored Raspberry 1oz/30ml - 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 Flavored Raspberry 1oz/30ml

Version/Model Number

10117

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

fa6ad5e9-e9bd-4533-a137-7f303a636a32

Public Version Date

September 09, 2022

Public Version Number

6

DI Record Publish Date

May 21, 2018

Additional Identifiers

Package DI Number

B362101171

Quantity per Package

24

Contains DI Package

B362101170

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