DUREX Intense Sensation Condom

GUDID 00302340096584

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00302340096584
• NIH Device Record Key: 938d4949-e694-4c26-9153-6d2de9ba9031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Intense Sensation Condom
• Version Model Number: Condom
• 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: 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
• 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 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00302340096584 [Package]; Contains: 99302340096588; Package: Carton [3 Units]; In Commercial Distribution
GS1	20302340096588 [Package]; Contains: 99302340096588; Package: Case [144 Units]; In Commercial Distribution
GS1	99302340096588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081886

FDA Product Code

• HIS: CONDOM

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: 2024-10-02
• Device Publish Date: 2023-07-13

On-Brand Devices [DUREX Intense Sensation Condom]

• 10302340096581: Condom
• 00023400824403: Condom
• 40302340082448: Condom
• 00302340096584: Condom