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.

• 00789091681588 - Nebulizer Kit: 2025-06-11 Disposable Nebulizer Kit with T-Piece, Jet Nebulizer, 7ft O2 Tubing - 5/pack
• 00848530060299 - Oxygen Connector/Adapter: 2025-06-11 Oxygen Tubing Connector Adapter with Female Port- 10/pack
• 10848530095229 - Tracheostomy and Suction Accessory: 2025-06-11 Deluxe Closed Suction System For Adult Tracheostomy with MDI Port - Size 16 FR
• 00848530100032 - Signage: 2025-06-11 Oxygen No Smoking Signs - 50/pack
• 00848530104474 - Tracheostomy and Suction Accessory: 2025-06-11 Pediatric Flexible Connector - 50/case
• 00848530105334 - SPO2 Sensor: 2025-06-11 Sunset SPO2 Sensor - Neonatal/Adult 3ft cord- NON-replaceable
• 10848530105348 - SpO2 Sensor: 2025-06-11 Sunset SPO2 Sensor - Infant (3-20kg) - 1.5ft cord
• 00848530105358 - SpO2 Sensor: 2025-06-11 Sunset SPO2 Sensor - Pediatric (10-50kg) - 1.5ft cord