Durex Intense Ultra Lube

GUDID 50302340996018

10 ct. Durex Intense Ultra Lube Nitrile Condom

RB Health (us) LLC

Basic male condom, synthetic polymer

• Primary Device ID: 50302340996018
• NIH Device Record Key: ed9af741-eb9c-4dc3-9736-14e3f51ee333
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durex Intense Ultra Lube
• Version Model Number: 00302340996013
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 10
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302340996013 [Primary]
GS1	50302340996018 [Package]; Contains: 00302340996013; Package: Case [18 Units]; In Commercial Distribution
GS1	99302340996017 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240896

FDA Product Code

• MOL: Condom, Synthetic

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: 2025-09-09
• Device Publish Date: 2025-09-01

On-Brand Devices [Durex Intense Ultra Lube]

• 50302340996025: 24 ct. Durex Intense Ultra Lube Nitrile Condom
• 50302340996018: 10 ct. Durex Intense Ultra Lube Nitrile Condom