Sunset Nasal Mask with Standard Headgear, Large, Non-Vented Elbow

GUDID 00848530101251

Sunset Nasal Mask with Standard Headgear, Large, Non-Vented Elbow

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00848530101251
• NIH Device Record Key: f1564f8d-8898-4ad8-9660-a505fc3b798b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Nasal Mask with Standard Headgear, Large, Non-Vented Elbow
• Version Model Number: CM008LVNV-10
• 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: false

Customer Support Contacts

• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com
• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530101251 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-12
• Device Publish Date: 2024-03-04

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530050627 - Oxygen Filter: 2026-01-12 Foam Cabinet 4 1/4'' x 6 3/4'' Compatible with: Nellcor Puritan Bennett # 492672-00 (592A & 590)
• 10848530108110 - DIATUBE002: 2025-12-31 Sunset Capillary Tube, 15uL - 10/pack
• 10848530107557 - Diabetics: 2025-12-29 Sunset Pressure Activated Lancet 21G, 2.0mm - 10/PK
• 00848530107949 - CPAP Filter: 2025-12-25 Private Labeled"Respironics DreamStation Reusable Filter - 1/PK
• 00848530107956 - CPAP Filter: 2025-12-25 Private Labeled" Respironics Dream Station 2 Reusable Filter - 1/PK
• 00848530107963 - CPAP Filter: 2025-12-25 Private Labeled"Resmed S9 & S10 CPAP Filter - 50/PK
• 00848530107970 - CPAP Filter: 2025-12-25 Private Labeled"Resmed AirMini CPAP Filter - 2/PK
• 00848530107987 - CPAP Filter: 2025-12-25 Private Labeled"Resmed AirMini CPAP Filter - 12/PK