Nasal CPAP Mask — Medium CM006MPL

GUDID 00848530088866

Includes 1 medium sized mask, with headgear and replaceable cushion.

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00848530088866
• NIH Device Record Key: 844e94d0-f39e-4548-b5f9-637a7598f7af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nasal CPAP Mask — Medium
• Version Model Number: CM006MPL
• Catalog Number: CM006MPL
• 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: true
• 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: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530088866 [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: 2018-08-31
• Device Publish Date: 2018-07-31

On-Brand Devices [Nasal CPAP Mask — Medium]

• 00848530088958: Includes 1 medium sized mask with headgear and replaceable cushion.
• 00848530088866: Includes 1 medium sized mask, with headgear and replaceable cushion.