ROSCOE

Basic Information

• Brand Name: ROSCOE
• Primary DI: 00092237623862
• Version / Model: ULTRA-5
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-03
• Public Version: 6
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: f242df84-2ad0-4354-9e82-3f5e364f1c08
• Distribution End Date: 2023-07-11

Device Description

ULTRA-5 ULTRAVIOLET DISINFECTOR (UV-C) - CPAP, CPAP ACCESSORIES, MULTIPURPOSE SANITIZER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEC	Disinfector, Medical Devices	General Hospital	880.6992	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65162	Ultraviolet device disinfection chamber	An electrically-powered unit including an ultraviolet radiation light source designed to destroy bacteria and viruses on small medical or non-medical devices (e.g., smartphones, hand-helds, weapons, tools) which are placed within its chamber. It is typically a cupboard-like device with doors and may have shelves inside. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30092237623863	GS1	CARTON	4	Not in Commercial Distribution	2023-07-11
Primary	00092237623862	GS1

Customer Contacts

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