ONE Intense Arousal

Basic Information

• Brand Name: ONE Intense Arousal
• Primary DI: 00726893112001
• Version / Model: 110605
• Company Name: GLOBAL PROTECTION CORP.
• Labeler DUNS: 364614362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2023-11-21
• Public Version: 2
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 173b68b4-3ba6-42de-8150-13fc51c7b893

Device Description

ONE Intense Arousal USA Piece- Includes 6 Assorted lubricated latex condoms and 6 One move lubricant sachets

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: 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	80726893112007	GS1
Primary	00726893112001	GS1
Package	20726893111046	GS1	Case of 72	72	In Commercial Distribution

Storage Conditions

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