KY True Feel Premium Silicone Lubricant

GUDID 10067981096740

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant

• Primary Device ID: 10067981096740
• NIH Device Record Key: 3b954cb3-94dc-4b09-a1a3-68fd2b891e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KY True Feel Premium Silicone 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 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	00067981096743 [Primary]
GS1	10067981096740 [Package]; Contains: 00067981096743; Package: Bottle [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173504

FDA Product Code

• NUC: Lubricant, personal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-21
• Device Publish Date: 2019-11-13

On-Brand Devices [KY True Feel Premium Silicone Lubricant]

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• 10067981096740: Personal Lubricant
• 20067981087899: Personal Lubricant
• 00067981941838: Personal Lubricants: Product Sizes are 0.16oz, 1.5oz, 4.5oz, 8.45oz
• 77067981953970: Personal Lubricant