Durex Air Close Fit Condom

Basic Information

• Brand Name: Durex Air Close Fit Condom
• Primary DI: 88302340876443
• Version / Model: Condom
• Company Name: RB Health (us) LLC
• Labeler DUNS: 081049410
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-03-27
• Public Version: 2
• Public Version Date: 2023-09-06
• Public Version Status: Update
• Public Device Record Key: e8333826-0599-47c4-9e83-5b2f1525a4ca
• Distribution End Date: 2023-09-04

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	10302340876442	GS1	Carton	3	Not in Commercial Distribution	2023-09-04
Primary	88302340876443	GS1
Package	20302340876449	GS1	Case	6	Not in Commercial Distribution	2023-09-04
Unit of Use	40302340876443	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
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.