DUREX RealFeel Non-Latex Condom

GUDID 20302340908058

Condom

RB Health (us) LLC

Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer Basic male condom, synthetic polymer

• Primary Device ID: 20302340908058
• NIH Device Record Key: f4c9af96-3ae0-481b-9ded-bf7c807f7257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX RealFeel Non-Latex Condom
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 36
• 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: false
• Labeled No Natural Rubber Latex: true
• 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
• 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
• 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	00302340908054 [Primary]
GS1	10302340908051 [Package]; Contains: 00302340908054; Package: Carton [6 Units]; In Commercial Distribution
GS1	20302340908058 [Package]; Contains: 10302340908051; Package: Case [3 Units]; In Commercial Distribution
GS1	40302340908052 [Unit of Use]
GS1	88302340908052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072169

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: 2020-01-30
• Device Publish Date: 2020-01-22

On-Brand Devices [DUREX RealFeel Non-Latex Condom]

• 20302340908058: Condom
• 00302340894562: Condom