DUREX® Variety Pack

Basic Information

• Brand Name: DUREX® Variety Pack
• Primary DI: 99302340995690
• Version / Model: Condom
• Company Name: RB Health (us) LLC
• Labeler DUNS: 081049410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 1
• Public Version Date: 2023-08-16
• Public Version Status: New
• Public Device Record Key: 21755fbb-2456-486a-86b3-d21e0a588d9f

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	00302340995696	GS1	Carton	144	In Commercial Distribution
Primary	99302340995690	GS1
Package	50302340995691	GS1	Case	6	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040185	000
K211152	000
K220489	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