DEVICE: Invacare Polaris EX Style Ultrafine Filters (00848530035303)
Device Identifier (DI) Information
Invacare Polaris EX Style Ultrafine Filters
CF9001
In Commercial Distribution
CF9001
SUNSET HEALTHCARE SOLUTIONS, INC.
CF9001
In Commercial Distribution
CF9001
SUNSET HEALTHCARE SOLUTIONS, INC.
Invacare Polaris EX Style Ultrafine Filters (3/pack)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
63172 | CPAP/BPAP unit ambient air filter, reusable |
A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JRL | Unit, Filter, Membrane |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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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No Device Sizes |
Device Record Status
f0aa4a64-16d1-46db-a5f6-a33e621db341
July 05, 2018
1
June 04, 2018
July 05, 2018
1
June 04, 2018
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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10848530035300
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-578-6738
customerservice@sunsethcs.com
customerservice@sunsethcs.com