DUREX Intense Sensation Condom

GUDID 00023400824403

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00023400824403
• NIH Device Record Key: 1e0ab7c4-5967-48fe-9b12-c589a69ec2ab
• Commercial Distribution Discontinuation: 2016-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DUREX Intense Sensation Condom
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 1000
• 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	00023400824403 [Primary]
GS1	10023400824400 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902509

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: 5
• Public Version Date: 2019-11-18
• Device Publish Date: 2016-09-20

On-Brand Devices [DUREX Intense Sensation Condom]

• 10302340096581: Condom
• 00023400824403: Condom
• 40302340082448: Condom
• 00302340096584: Condom