KY Warming Jelly

GUDID 77067981993778

Lubricant

RB Health (us) LLC

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• Primary Device ID: 77067981993778
• NIH Device Record Key: ec2f36fb-81b6-4eb3-a3e0-8a54cd0c4251
• Commercial Distribution Discontinuation: 2023-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KY Warming Jelly
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	77067981993778 [Package]; Contains: 88067981993774; Package: Case [24 Units]; Discontinued: 2023-12-05; Not in Commercial Distribution
GS1	88067981993774 [Package]; Contains: 99067981993770; Package: Carton [1 Units]; Discontinued: 2023-12-05; Not in Commercial Distribution
GS1	99067981993770 [Primary]

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: 2
• Public Version Date: 2023-12-07
• Device Publish Date: 2023-04-27

On-Brand Devices [KY Warming Jelly ]

• 10067981993773: Lubricant
• 77067981993778: Lubricant