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.
00084853040437
GS1

1
141668116 *Terms of Use
Deluxe Full Face Mask Replacement Cushion - Large
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
Yes
No
No
No

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
BZD Ventilator, Non-Continuous (Respirator)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K063268 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Large
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Device Record Status

6aababc5-a63d-4b5e-a041-c2df0beba00f
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
877-578-6738
customerservice@sunsethcs.com
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