KY® Jelly

GUDID 77067981993730

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant

• Primary Device ID: 77067981993730
• NIH Device Record Key: 6028ae5b-b9f5-4ab5-aec1-9fac2ce79370
• Commercial Distribution Discontinuation: 2023-11-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KY® Jelly
• Version Model Number: Personal Lubricant
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com
• Phone: +1-800-756-5488
• Email: xxx.xxx@xxx.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	20067981993732 [Package]; Package: Case [4 Units]; Discontinued: 2023-11-28; Not in Commercial Distribution
GS1	40067981993736 [Unit of Use]
GS1	77067981993730 [Package]; Contains: 88067981993736; Package: Carton [12 Units]; Discontinued: 2023-11-28; Not in Commercial Distribution
GS1	88067981993736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201186

FDA Product Code

• NUC: Lubricant, Personal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-02-17

On-Brand Devices [KY® Jelly]

• 10067981993735: Personal Lubricant
• 77067981993730: Personal Lubricant