DUREX® Air Regular Fit

GUDID 10302340995662

Condom

RB Health (us) LLC

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• Primary Device ID: 10302340995662
• NIH Device Record Key: 2a1c1f3c-145a-4bc6-80d7-20b3b897cb6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX® Air Regular Fit
• Version Model Number: Condom
• 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: 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

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	00302340995665 [Primary]
GS1	10302340995662 [Package]; Contains: 00302340995665; Package: Carton [3 Units]; In Commercial Distribution
GS1	20302340995669 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	40302340995663 [Unit of Use]

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: 2023-03-30
• Device Publish Date: 2023-03-22

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• 77067981993778 - KY Warming Jelly: 2023-12-07 Lubricant
• 77067981993730 - KY® Jelly: 2023-11-30 Personal Lubricant
• 00067981089028 - KY Personal Lubricant Jelly: 2023-11-30 Personal Lubricant
• 00067981957525 - DUREX Pleasure Ring: 2023-11-22 Penile Rigidity Ring
• 00302340301602 - DUREX Play Vibrations Ring: 2023-11-22 Contains: 1 Condom 1 General Product (Vibrating Ring)