KY UltraGel Personal Lubricant

GUDID 00067981993936

Personal Lubricant 8.45

RB Health (us) LLC

Vaginal lubricant

• Primary Device ID: 00067981993936
• NIH Device Record Key: 265460d9-1ff8-4598-8049-95c35a29e6d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KY UltraGel Personal Lubricant
• Version Model Number: 00067981993936
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 1
• 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: false
• 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
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx
• Phone: +1(800)756-5488
• Email: xxx@xxx.xxx

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00067981993936 [Primary]
GS1	10067981993933 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192982

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: 2025-12-10
• Device Publish Date: 2022-03-16

On-Brand Devices [KY UltraGel Personal Lubricant]

• 10067981087373: Personal Lubricant
• 10067981087359: Personal Lubricant
• 10067981088073: Personal Lubricant
• 00067981993936: Personal Lubricant 8.45
• 00067981087932: Personal Lubricant 4.5oz.
• 00067981087925: Personal Lubricant 1.5oz.