Deluxe Nasal CPAP Mask with Removable Cushion - Large CM006L

GUDID 10848530040403

Sunset Healthcare Solutions Deluxe Nasal CPAP Mask with Removable Cushion, Headgear and SHS Labeled Bag - Large

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 10848530040403
• NIH Device Record Key: da5a4290-9414-4446-b099-511ed7859417
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deluxe Nasal CPAP Mask with Removable Cushion - Large
• Version Model Number: CM006L
• Catalog Number: CM006L
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530040406 [Primary]
GS1	10848530040403 [Package]; Contains: 00848530040406; Package: Corrugated Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063268

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530108168 - Regulators: 2026-02-10 Private Labeled - Standard CGA 870 Regulator, 1-DISS, 0-25LPM
• 10848530108172 - CPAP Accessory: 2026-02-10 Sunset Nasal Gel Pad - 5/PK
• 00848530108267 - Filter - Vent: 2026-02-10 Luisa Gross Particle Internal Filter - 1/PK
• 10848530108271 - CPAP Tubing: 2026-02-10 Adapter for Resmed S10 Heated CPAP Tube System
• 00848530108298 - CPAP Filter: 2026-02-04 Filter, USA, Standard S9, AirSense 10, AirCurve, 2/pack
• 00848530107932 - Nebulizer and Compressor: 2026-02-03 Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit
• 10848530108127 - Regulator: 2026-02-03 Standard CGA 870 Regulator, 1-DISS, 0-25LPM
• 00848530108137 - CPAP Filter: 2026-02-03 Filter, USA, Airsense 11, Standard, 50/Pack