DUREX Massage & Play - Soothing Touch 2 in 1 Lubricant - Aloe Vera

GUDID 10302340876374

Personal Lubricant

RB Health (us) LLC

Vaginal lubricant

• Primary Device ID: 10302340876374
• NIH Device Record Key: e57a432d-f612-4b7c-9e2a-7139311bf9fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Massage & Play - Soothing Touch 2 in 1 Lubricant - Aloe Vera
• 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	00302340876377 [Primary]
GS1	10302340876374 [Package]; Contains: 00302340876377; Package: Bottle [3 Units]; In Commercial Distribution
GS1	20302340876371 [Package]; 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

Devices Manufactured by RB Health (us) LLC

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• 50302340876570 - DUREX® Air Regular Fit; DUREX® Air: 2025-03-21 Durex Air Regular Fit Condom 36ct. Durex Air Condom 36ct.
• 20302340090005 - DUREX Tropical Condoms: 2025-03-21 DUREX Tropical Condoms 3ct.
• 50302340129003 - DUREX Extra Sensitive Condom: 2025-03-21 Extra Sensitive Thin Condom 3ct. Extra Sensitive Thin Regular Fit 3ct.
• 50302340876600 - DUREX Extra Sensitive Condom: 2025-03-21 Extra Sensitive Thin Condom 24ct. Extra Sensitive Thin Regular Fit 24ct.