Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear*

Basic Information

• Brand Name: Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear*
• Primary DI: 00848530040734
• Version / Model: CM005LNH
• Catalog Number: CM005LNH
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: eb221040-f98d-418e-ab1b-f1dadcc7aa94

Device Description

Sunset Healthcare Solutions Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear*

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: 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: Yes
• 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
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	868.5905	2

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
Primary	00848530040734	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063268	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Large