CPAP Mask Cushion

GUDID 00848530091095

Deluxe Full Face Mask Replacement Cushion — Large

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable

• Primary Device ID: 00848530091095
• NIH Device Record Key: 18940ee1-9b83-4364-998c-33a9c2cfdbf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPAP Mask Cushion
• Version Model Number: ASCM002CUCM005L
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: false

Customer Support Contacts

• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530091095 [Primary]

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-28
• Device Publish Date: 2024-06-20

On-Brand Devices [CPAP Mask Cushion]

• 00848530091095: Deluxe Full Face Mask Replacement Cushion — Large
• 00848530091088: Deluxe Full Face Mask Replacement Cushion — Medium
• 00848530091064: Deluxe Nasal Mask Replacement Cushion — Large
• 00848530091057: Deluxe Full Face Mask Replacement Cushion — Medium
• 00848530091040: Deluxe Full Face Mask Replacement Cushion — Small
• 00848530090654: Clearsight Deluxe Nasal Mask Replacement Cushion — Large
• 00848530090647: Clearsight Deluxe Nasal Mask Replacement Cushion — Medium
• 00848530090630: Clearsight Deluxe Nasal Mask Replacement Cushion — Small
• 00848530085223: Deluxe Nasal Mask Replacement Cushion - Small