KY UltraGel Personal Lubricant

GUDID 10067981087373

Personal Lubricant

RB Health (us) LLC

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