DEVICE: AF531 (00606959007468)
Device Identifier (DI) Information
AF531
AF531 Mask w/SE, with 4 point Headgear, Medium, SU
Not in Commercial Distribution
1061722
Respironics, Inc.
AF531 Mask w/SE, with 4 point Headgear, Medium, SU
Not in Commercial Distribution
1061722
Respironics, Inc.
AF531 Mask with Standard Elbow, with 4 Point Headgear, Single Use, Medium
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
57813 | CPAP/BPAP face mask, single-use |
A non-sterile, 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/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 single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBK | VENTILATOR, CONTINUOUS, FACILITY USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K101129 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
31192e25-1f36-42e2-a510-9a79edab4f89
October 27, 2022
5
June 10, 2016
October 27, 2022
5
June 10, 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 |
---|---|---|---|---|---|
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
[?]
+1(724)744-2500
respironics.service@philips.com
respironics.service@philips.com