ID Jelly

Basic Information

• Brand Name: ID Jelly
• Primary DI: 10761236109826
• Version / Model: IDDKRPJ0
• Company Name: WESTRIDGE LABORATORIES INCORPORATED
• Labeler DUNS: 879057065
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 144
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 515c038a-c34e-48d6-985a-ae2c5b83bb98
• Distribution End Date: 2016-10-12

Device Description

ID Jelly is a water based personal lubricant, and is compatible with Latex & Polyurethane Condoms. This is a set of 144 ID Jelly 10 ml Pillows, clear plastic pouches, packaged into a clear plastic jar and bag.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUC	Lubricant, Personal	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34131	Vaginal lubricant	A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10761236109826	GS1
Unit of Use	90761236000006	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter