Sunset Healthcare Solutions Deluxe Nasal Mask Replacement Cushion - Medium CUCM006M

GUDID 10848530040458

Deluxe Nasal Mask Replacement Cushion - Medium

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 10848530040458
• NIH Device Record Key: 33575e7d-6728-4774-8ac4-355d51fd3ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Healthcare Solutions Deluxe Nasal Mask Replacement Cushion - Medium
• Version Model Number: CUCM006M
• Catalog Number: CUCM006M
• 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: false
• OTC Over-The-Counter: true

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	00848530040451 [Primary]
GS1	10848530040458 [Package]; Contains: 00848530040451; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530108618 - CPAP Filter: 2026-03-27 Replacement Reusable Foam Filter 2/pkg ResPlus Oxygo AutoPAP Machine
• 00848530108632 - CPAP Tubing: 2026-03-27 Premium CPAP Tube, Rubber Cuffs, Gray, 8 ft.
• 00848530108472 - Oxygen, Bacteria & HEPA Filter: 2026-03-25 Invarecare 50PSI Foam Inlet Filter - 10/PK
• 00848530108489 - CPAP Filter: 2026-03-25 Filter, USA, AirSense 11, Standard 12 per pack
• 10848530108646 - Repair Parts: 2026-03-25 Heat Exchanger Assembly for Perfecto2 and Perfecto2V
• 00848530108656 - Repair Parts: 2026-03-25 Invacare Platinum 10L Flow Meter
• 10848530108660 - Repair Parts: 2026-03-25 Sieve Everflo Muffler Insulation
• 10848530108677 - Repair Parts: 2026-03-25 P2 Compressor Rebuild Kit with Top End and Bottom Flapper Assembly + Cup and Sleeve