DUREX® Air Regular Fit; DUREX® Air

GUDID 50302340876570

Durex Air Regular Fit Condom 36ct. Durex Air Condom 36ct.

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 50302340876570
• NIH Device Record Key: a978cd45-22b3-45b4-a1b4-216344692826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX® Air Regular Fit; DUREX® Air
• Version Model Number: 00067981087994
• 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: 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00067981087994 [Primary]
GS1	50302340876570 [Package]; Contains: 00067981087994; Package: Case [18 Units]; In Commercial Distribution
GS1	99067981087981 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222068

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: 2025-03-21
• Device Publish Date: 2025-03-13

On-Brand Devices [DUREX® Air Regular Fit; DUREX® Air ]

• 50302340876587: Durex Air Regular Fit Condom 24ct. Durex Air Condom 24ct.
• 50302340876570: Durex Air Regular Fit Condom 36ct. Durex Air Condom 36ct.
• 10067981087984: Durex Air Regular Fit Condom 10ct. Durex Air Condom 10ct.