DUREX Invisible Condom

GUDID 20302340912772

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 20302340912772
• NIH Device Record Key: 53fe8f48-e199-4c2a-8120-a03b1c751a04
• 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: 8
• 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	00302340912778 [Primary]
GS1	10302340912775 [Package]; Contains: 00302340912778; Package: Carton [3 Units]; In Commercial Distribution
GS1	20302340912772 [Package]; Contains: 10302340912775; Package: Case [16 Units]; In Commercial Distribution
GS1	40302340912776 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-13
• Device Publish Date: 2016-09-20

On-Brand Devices [DUREX Invisible Condom]

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