DUREX Pleasure Pack Condom

Basic Information

• Brand Name: DUREX Pleasure Pack Condom
• Primary DI: 00302340958837
• Version / Model: Condom
• Company Name: RB Health (us) LLC
• Labeler DUNS: 081049410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2020-03-04
• Public Version: 1
• Public Version Date: 2020-03-12
• Public Version Status: New
• Public Device Record Key: 542ad4fb-a58f-4ed3-aab3-0e36b5f16483

Device Description

Condom

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
MOL	Condom, synthetic	Obstetrics/Gynecology	884.5300	2
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
34151	Basic male condom, synthetic polymer	A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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	10302340958834	GS1	Carton	18	In Commercial Distribution
Primary	00302340958837	GS1
Unit of Use	40302340958835	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020659	000
K072169	000
K980319	000

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