CPAP Accessories

GUDID 00848530099732

Pediatric Nasal CPAP Mask Cushion Replacement – Adult XS

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00848530099732
• NIH Device Record Key: 9cc5e853-50a6-4bd3-b3a5-c6c4c9a23592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPAP Accessories
• Version Model Number: CUCM060XS
• 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: false
• 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: false
• 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
• 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	00848530099732 [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: 2024-07-05
• Device Publish Date: 2024-06-27

On-Brand Devices [CPAP Accessories]

• 00848530099862: CPAP accessories kit
• 00848530092535: Filter and Check Valve Kit for SoClean
• 00848530099732: Pediatric Nasal CPAP Mask Cushion Replacement – Adult XS
• 00848530099282: Pediatric Nasal CPAP Mask Kit with L/XL Cushions
• 00848530099268: Pediatric Nasal CPAP Mask Kit with S/M Cushions
• 00848530040536: Replacement Headgear Clips for Sunset Masks with Removable Cushions - 1pr/pkg.
• 10848530091153: Soft Headgear Strap Covers