ONE Flex

Basic Information

• Brand Name: ONE Flex
• Primary DI: 00726893115132
• Version / Model: 1131010
• Company Name: GLOBAL PROTECTION CORP.
• Labeler DUNS: 364614362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-10-16
• Public Version: 1
• Public Version Date: 2023-10-24
• Public Version Status: New
• Public Device Record Key: 946a6424-5f34-4dd8-99d4-b03b8890b7f1

Device Description

one flex- Latex Lubricated Condoms

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: No
• 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	10726893115139	GS1	bundle of 3	3	In Commercial Distribution
Primary	00726893115132	GS1
Unit of Use	80726893115138	GS1

Premarket Submissions

Submission Number	Supplement Number
K203536	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature in a dark, dry place. Avoid excessive heat.