Zoey CPAP Cleaner

Basic Information

• Brand Name: Zoey CPAP Cleaner
• Primary DI: 00848530090890
• Version / Model: ZCD100
• Catalog Number: ZCD100
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-28
• Public Version: 3
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 3bf24a8d-c201-4111-bd22-54a7da03b08d

Device Description

CPAP Cleaning Device

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
61383	Home CPAP/BPAP washer-disinfector (ozone)	A portable, electrically-powered device designed for the cleaning/disinfection of home positive airway pressure ventilation units (i.e., home CPAP unit, home BPAP unit) and/or masks (e.g., CPAP/BPAP oral mask) using ozone gas as the disinfecting agent. It is a small desktop unit with controls and an integrated ozone generator. It is intended for use in the home but may also be used in healthcare facilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10848530090897	GS1	Outer packaging	4	In Commercial Distribution
Primary	00848530090890	GS1

Customer Contacts

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