DEVICE: Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Large (00084853040437)
Device Identifier (DI) Information
Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Large
CUCM005L
In Commercial Distribution
CUCM005L
SUNSET HEALTHCARE SOLUTIONS, INC.
CUCM005L
In Commercial Distribution
CUCM005L
SUNSET HEALTHCARE SOLUTIONS, INC.
Deluxe Full Face Mask Replacement Cushion - Large
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
CPAP/BPAP face mask, reusable | A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZD | Ventilator, Non-Continuous (Respirator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K063268 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Large |
Device Record Status
6aababc5-a63d-4b5e-a041-c2df0beba00f
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-578-6738
customerservice@sunsethcs.com
customerservice@sunsethcs.com