DUREX Air Condom

GUDID 20067981087998

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex

• Primary Device ID: 20067981087998
• NIH Device Record Key: c0e7df2c-f93d-417f-847e-24a1e727b8d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Air 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: 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
• 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
• 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	10067981087991 [Package]; Contains: 00067981087994; Package: Carton [3 Units]; In Commercial Distribution
GS1	20067981087998 [Package]; Contains: 10067981087991; Package: Case [6 Units]; In Commercial Distribution
GS1	40067981087992 [Unit of Use]
GS1	88067981087992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200672

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: 2021-03-17
• Device Publish Date: 2021-03-09

On-Brand Devices [DUREX Air Condom]

• 10302340876428: Condom
• 20067981087998: Condom
• 20067981087981: Condom
• 10067981087977: Condom
• 77067981087972: Condom
• 99067981087981: Condom