Classic Full Face CPAP Mask with Headgear - Large CM007L

GUDID 10848530040007

Sunset Healthcare Solutions Classic Full Face CPAP Mask with Headgear - Large

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable

• Primary Device ID: 10848530040007
• NIH Device Record Key: 49c20fcc-e056-4e0f-a6c2-cae3dd7a6695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Classic Full Face CPAP Mask with Headgear - Large
• Version Model Number: CM007L
• Catalog Number: CM007L
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

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	00848530040000 [Primary]
GS1	10848530040007 [Package]; Contains: 00848530040000; Package: Corrugated Box [50 Units]; In Commercial Distribution

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: 2016-09-24

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530108434 - Oxygen Kit: 2026-02-26 Oxygen Kit (6- RES1107S, 1- RES3050G,2- RES012, 2 -RES001)
• 00848530108311 - Oxygen Kit: 2026-02-19 10L Oxygen Supply Kit 4 RES1107SHF High Flow Soft Cannula with 7ft Supply Tube 2 RES003 No Smoking Sign 2 RES3025G Oxygen Suppl
• 00848530108335 - Repair Parts: 2026-02-19 CAIRE Contents Gauge Tubing (OEM# B-775856-SV) - 2/PK
• 00848530108342 - Repair Parts: 2026-02-19 C1000/C1000T Portable Rubber Foot - 56/Sheet - 10 Sheet/Case - (OEM# B-775010-00)
• 00848530108168 - Regulators: 2026-02-10 Private Labeled - Standard CGA 870 Regulator, 1-DISS, 0-25LPM
• 10848530108172 - CPAP Accessory: 2026-02-10 Sunset Nasal Gel Pad - 5/PK
• 00848530108267 - Filter - Vent: 2026-02-10 Luisa Gross Particle Internal Filter - 1/PK
• 10848530108271 - CPAP Tubing: 2026-02-10 Adapter for Resmed S10 Heated CPAP Tube System