KY Warming Jelly Lubricant

GUDID 10067981089483

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant

• Primary Device ID: 10067981089483
• NIH Device Record Key: 6af8e005-a0c1-46f1-9b51-48cc6d356503
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KY Warming Jelly 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

Operating and Storage Conditions

• 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	00067981089486 [Primary]
GS1	10067981089483 [Package]; Contains: 00067981089486; Package: Tube [6 Units]; In Commercial Distribution
GS1	20067981089480 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040164

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 Warming Jelly Lubricant]

• 10067981089483: Personal Lubricant
• 10067981089476: Personal Lubricant
• 00067981089479: Personal Lubricant
• 77067981089488: Personal Lubricant