Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Medium CUCM005M

GUDID 00848530040420

Deluxe Full Face Mask Replacement Cushion - Medium

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00848530040420
• NIH Device Record Key: 49d4ce66-6c54-4f8f-9904-5f4cf4f1a183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Medium
• Version Model Number: CUCM005M
• Catalog Number: CUCM005M
• 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: false
• RX Perscription: false
• 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	00848530040420 [Primary]
GS1	10848530040427 [Package]; Package: [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: 2018-09-03
• Device Publish Date: 2016-09-24

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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• 00848530106508 - Perform Health PrecisionFit Full Face Cushion - Large: 2025-07-30 CPAP Cusion - Large
• 10848530106710 - CPAP Carry Bag for ResMed AirSense 11: 2025-07-29 CPAP Carry Bag
• 00848530106447 - Oxygen Kit: 2025-07-25 Oxygen Kit- This kit: RES1107(4) RES3025 (2) RES032 (1) RES035 (1) RES012 (2) RES003 (1)