AccessGUDID - DEVICE: Just for Us (00855424008527)

GUDID

Device Identifier (DI) Information

Brand Name: Just for Us
Version or Model: JFU00852
Commercial Distribution Status: In Commercial Distribution
Catalog Number: JFU00852
Company Name: MKJ Brands Limited Liability Company

Primary DI Number: 00855424008527
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827648101 *Terms of Use

Device Description: Just for Us™ Warming Jelly Water-based Personal Lubricant

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60412	Sexual lubricant	A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUC	Lubricant, Personal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cbced9fd-7046-4392-bb9f-c5e760b0bdcd
Public Version Date: December 03, 2024
Public Version Number: 1
DI Record Publish Date: November 25, 2024