DUREX Extra Sensitive Stimulating Condom

GUDID 20067981160479

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 20067981160479
• NIH Device Record Key: c73a3a7a-5cf4-48fe-90f3-c7ecd8eac52c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Extra Sensitive Stimulating Condom
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 12
• 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	00067981160475 [Primary]
GS1	10067981160472 [Package]; Contains: 00067981160475; Package: Carton [3 Units]; In Commercial Distribution
GS1	20067981160479 [Package]; Contains: 10067981160472; Package: Case [6 Units]; In Commercial Distribution
GS1	40067981160473 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040185

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: 2020-04-17
• Device Publish Date: 2020-04-09

Devices Manufactured by RB Health (us) LLC

• 00302340300490 - DUREX® Pleasure Pack: 2025-03-28 Durex Pleasure Pack Condom - 3ct. Contains: Extra Sensitive Thin - 1ct. Extra Sensitive Stimulating - 1ct. Performax Intense -
• 50302340989331 - DUREX® Pleasure Pack: 2025-03-28 Durex Pleasure Pack Condom - 42ct. Contains: Extra Sensitive Thin - 11ct. Extra Sensitive Smooth - 10ct. Extra Sensitive Stimul
• 50302340995691 - DUREX® Adventure Pack: 2025-03-28 Durex Adventure Pack Condom - 144ct. Contains: Extra Sensitive Smooth - 48ct. Extra Sensitive Stimulating - 48ct. Performax Int
• 10067981087984 - DUREX® Air Regular Fit; DUREX® Air: 2025-03-21 Durex Air Regular Fit Condom 10ct. Durex Air Condom 10ct.
• 50302340876570 - DUREX® Air Regular Fit; DUREX® Air: 2025-03-21 Durex Air Regular Fit Condom 36ct. Durex Air Condom 36ct.
• 20302340090005 - DUREX Tropical Condoms: 2025-03-21 DUREX Tropical Condoms 3ct.
• 50302340129003 - DUREX Extra Sensitive Condom: 2025-03-21 Extra Sensitive Thin Condom 3ct. Extra Sensitive Thin Regular Fit 3ct.
• 50302340876600 - DUREX Extra Sensitive Condom: 2025-03-21 Extra Sensitive Thin Condom 24ct. Extra Sensitive Thin Regular Fit 24ct.