DUREX Extra Sensitive Smooth Condom

GUDID 10067981160489

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 10067981160489
• NIH Device Record Key: 176f3a85-449d-426e-8083-12735dc310d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Extra Sensitive Smooth Condom
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 12
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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 (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00067981160482 [Primary]
GS1	10067981160489 [Package]; Contains: 00067981160482; Package: Carton [3 Units]; In Commercial Distribution
GS1	20067981160486 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	40067981160480 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980319

FDA Product Code

• HIS: CONDOM

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: 2020-04-17
• Device Publish Date: 2020-04-09

Devices Manufactured by RB Health (us) LLC

• 00302340096584 - DUREX Intense Sensation Condom: 2024-10-02 Condom
• 00302340300452 - DUREX Classic XXL and DUREX Classic Condom: 2024-10-02 Condom
• 77067981089488 - KY Warming Jelly Lubricant: 2023-12-07 Personal Lubricant
• 10067981087106 - KY Warming Liquid Lubricant: 2023-12-07 Personal Lubricant
• 00067981089479 - KY Warming Jelly Lubricant: 2023-12-07 Personal Lubricant
• 77067981993778 - KY Warming Jelly: 2023-12-07 Lubricant
• 77067981993730 - KY® Jelly: 2023-11-30 Personal Lubricant
• 00067981089028 - KY Personal Lubricant Jelly: 2023-11-30 Personal Lubricant