KY UltraGel Personal Lubricant

GUDID 10067981087373

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

• Primary Device ID: 10067981087373
• NIH Device Record Key: db442366-be01-46e5-b8d6-67a355cc5cba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KY UltraGel Personal Lubricant
• Version Model Number: Personal Lubricant
• 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
• 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 below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)
• Special Storage Condition, Specify: Between 0 and 0 *Store below 77° F (25° C)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00067981087376 [Primary]
GS1	10067981087373 [Package]; Contains: 00067981087376; Package: Carton [4 Units]; In Commercial Distribution
GS1	20067981087370 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020827

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: 5
• Public Version Date: 2019-10-24
• Device Publish Date: 2016-09-20

On-Brand Devices [KY UltraGel Personal Lubricant]

• 10067981087373: Personal Lubricant
• 10067981087359: Personal Lubricant
• 10067981088073: Personal Lubricant