DEVICE: N/A (00607411943768)
Device Identifier (DI) Information
N/A
HYB555
Not in Commercial Distribution
HYB555
SALTER LABS
HYB555
Not in Commercial Distribution
HYB555
SALTER LABS
Hybrid AV Face Mask –LG, pack of 5
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57816 | CPAP/BPAP oral mask |
A flexible, form-shaped device designed to be fitted to the user's 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 patient's mouth; this providing a solution for mouth breathers and patients with chronic nasal obstruction. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZD | Ventilator, Non-Continuous (Respirator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K062224 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e091015e-3e25-446e-9c62-6d5597031248
February 28, 2025
5
September 03, 2017
February 28, 2025
5
September 03, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10607411943765 | 15 | 00607411943768 | 2025-02-28 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1(800)421-0024
customercare@salterlabs.com
customercare@salterlabs.com