Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Large CUCM005L

GUDID 00084853040437

Deluxe Full Face Mask Replacement Cushion - Large

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00084853040437
• NIH Device Record Key: 6aababc5-a63d-4b5e-a041-c2df0beba00f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Large
• Version Model Number: CUCM005L
• Catalog Number: CUCM005L
• 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	00084853040437 [Primary]

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

On-Brand Devices [Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Large]

• 00084853040437: Deluxe Full Face Mask Replacement Cushion - Large
• 00848530040437: Deluxe Full Face Mask Replacement Cushion - Large