DUREX Invisible Condom

GUDID 10302340983553

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 10302340983553
• NIH Device Record Key: bf173371-7769-421c-b8f9-aa86309fd9ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Invisible Condom
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 16
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302340983556 [Primary]
GS1	10302340983553 [Package]; Contains: 00302340983556; Package: Carton [2 Units]; In Commercial Distribution
GS1	20302340983550 [Package]; Package: Case [9 Units]; In Commercial Distribution
GS1	40302340983554 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980319

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: 2019-11-07
• Device Publish Date: 2019-10-30

On-Brand Devices [DUREX Invisible Condom]

• 10302340912782: Condom
• 20302340912772: Condom
• 20302340912765: Condom
• 10302340983553: Condom