DUREX Intense Sensation Condom

Basic Information

• Brand Name: DUREX Intense Sensation Condom
• Primary DI: 88302340096582
• Version / Model: Condom
• Company Name: RB Health (us) LLC
• Labeler DUNS: 081049410
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 7
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 37a57702-2c99-48be-9ee8-99e011e45cbb
• Distribution End Date: 2023-07-12

Device Description

Condom

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIS	CONDOM	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45138	Basic male condom, Hevea-latex	A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10302340096581	GS1	Carton	6	Not in Commercial Distribution	2023-07-12
Primary	88302340096582	GS1
Package	77302340096586	GS1	Case	24	Not in Commercial Distribution	2023-07-12
Unit of Use	40302340096582	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat