DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana

GUDID 20302340876395

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant

• Primary Device ID: 20302340876395
• NIH Device Record Key: 72a7b362-0352-4155-a220-4a383aeaadbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana
• 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 at room temperature and avoid excess heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302340876391 [Primary]
GS1	10302340876398 [Package]; Contains: 00302340876391; Package: Bottle [3 Units]; In Commercial Distribution
GS1	20302340876395 [Package]; Contains: 10302340876398; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063385

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

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