One

Basic Information

• Brand Name: One
• Primary DI: 00726893115125
• Version / Model: 1131006
• Company Name: GLOBAL PROTECTION CORP.
• Labeler DUNS: 364614362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2024-02-06
• Public Version: 1
• Public Version Date: 2024-02-14
• Public Version Status: New
• Public Device Record Key: 01765e98-ad55-4b15-a376-c90d0c8d7bed

Device Description

ONE Flex 3-Pack,

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
Unit of Use	80726893115121	GS1
Primary	00726893115125	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.