CPAP Masks

Basic Information

• Brand Name: CPAP Masks
• Primary DI: 00848530097561
• Version / Model: CM205M
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-07-29
• Public Version: 3
• Public Version Date: 2026-04-23
• Public Version Status: Update
• Public Device Record Key: cae9e287-6ffe-4fc2-bcdd-0d4ec83938db

Device Description

Sunset Sol Full Face CPAP Mask with Medium Frame and Cushion, Headgear and SHS Labeled Bag

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	868.6175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57814	CPAP/BPAP face mask, reusable	A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10848530097568	GS1
Primary	00848530097561	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K203347	000