CPAP Mask

GUDID 00848530106539

Sunset Vesper Full Face CPAP Mask - Large

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00848530106539
• NIH Device Record Key: 74dabdc3-7a3f-4551-8a86-7fe52bcd5ce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPAP Mask
• Version Model Number: CM206L
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530106539 [Primary]
GS1	10848530106536 [Package]; Package: [10 Units]; In Commercial Distribution

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: 2025-07-25
• Device Publish Date: 2025-07-17

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• 00848530098032: Novaplus Full Face Mask, Standard Elbow, with Standard Headgear, Medium-each
• 00848530098025: Novaplus Full Face Mask, Standard Elbow, with Standard Headgear, Small-each
• 00848530098018: Novaplus Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Large-each
• 00848530098001: Novaplus Full Face Mask, Single Limb Elbow Vented, with Standard Headgear, Medium-each
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• 00848530097981: Novaplus Full Face Mask, Single Limb Elbow, with Standard Headgear, Large-each
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• 00848530088941: Nasal CPAP Mask — Small
• 00848530097493: Novaplus Nasal Mask with Standard Headgear, Large
• 00848530097486: Novaplus Nasal Mask with Standard Headgear, Medium
• 00848530097479: Novaplus Nasal Mask with Standard Headgear, Small
• 00848530099473: Pediatric Full Face CPAP Mask Headgear – Small
• 00848530099459: Pediatric Full Face CPAP Mask Headgear – Large
• 00848530099435: Pediatric Full Face CPAP Mask Cushion Replacement – XL
• 00848530099411: Pediatric Full Face CPAP Mask Cushion Replacement – Small
• 00848530099398: Pediatric Full Face CPAP Mask Cushion Replacement – Medium
• 00848530099374: Pediatric Full Face CPAP Mask Cushion Replacement – Large
• 00848530099350: Pediatric Full Face CPAP Mask - XL
• 00848530099336: Pediatric Full Face CPAP Mask - Small
• 00848530099312: Pediatric Full Face CPAP Mask - Medium
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• 00848530106379: Pediatric Full Face CPAP/VPAP Mask, Medium- 10/pack
• 00848530106355: Pediatric Full Face CPAP/VPAP Mask, Large - 10/pack
• 10848530106628: Replacement Cushion for Sunset Vesper Nasal CPAP Mask - Large
• 10848530106611: Replacement Cushion for Sunset Vesper Nasal CPAP Mask - Medium
• 10848530106604: Replacement Cushion for Sunset Vesper Nasal CPAP Mask - Small
• 10848530106598: Sunset Vesper Nasal CPAP Mask - Large
• 00848530106584: Sunset Vesper Nasal CPAP Mask - Medium
• 10848530106574: Sunset Vesper Nasal CPAP Mask - Small
• 10848530106567: Replacement Cushion for Sunset Vesper Full Face CPAP Mask - Large
• 10848530106550: Replacement Cushion for Sunset VesperFull Face CPAP Mask - Medium
• 10848530106543: Replacement Cushion for Sunset Vesper Full Face CPAP Mask - Small
• 00848530106539: Sunset Vesper Full Face CPAP Mask - Large
• 10848530106529: Sunset Vesper Full Face CPAP Mask - Medium