Deluxe Nasal CPAP Mask with Removable Cushion - Large *No Headgear* - Retail CM006LNH-RP

GUDID 00848530080563

Sunset Healthcare Solutions Deluxe Nasal CPAP Mask with Removable Cushion - Large *No Headgear* - Retail Packaging

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00848530080563
• NIH Device Record Key: f6db26e6-2a33-4780-95cd-3add9ffefb26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deluxe Nasal CPAP Mask with Removable Cushion - Large *No Headgear* - Retail
• Version Model Number: CM006LNH-RP
• Catalog Number: CM006LNH-RP
• 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: 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: 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	00848530080563 [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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-11

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530040291 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hook s - Adult Small
• 00848530040307 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Medium
• 00848530040314 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Adult Large
• 00848530104214 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Infant
• 00848530104221 - Oxygen Masks: 2024-08-23 Sunset Breathing Mask, No Hooks - Toddler
• 10848530091290 - Power and Accessories: 2024-08-16 Portable Suction Machine DC Mobile Power Adapter
• 00848530091378 - Portable Suction: 2024-08-16 Portable Suction Machine AC
• 10848530091870 - Power and Accessories: 2024-08-16 Replacement Battery for SU100DC Portable Suction Machine