DEVICE: Shelco Filtration System (B297APT5061100PRECARB0)
Device Identifier (DI) Information
Shelco Filtration System
A-PT-5061-100-PRE-CARB
In Commercial Distribution
SPECIALITY WATER TECHNOLOGY
A-PT-5061-100-PRE-CARB
In Commercial Distribution
SPECIALITY WATER TECHNOLOGY
Pre-Carbons 1" Shelco Housing Assembly, Holds (4) 20” Filters, 5-Micron, With Bypass Valves
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
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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? |
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35433 | Particulate water purification filter |
A device designed to remove sediment and other suspended particles from flowing water by creating a mechanical barrier to elements larger than a specified size (e.g., 5 to 10 microns/micrometres); it is often made of polypropylene filaments.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FIP | Subsystem, Water Purification |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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
6e03a7a5-0655-463a-b741-96581cb0af53
March 29, 2018
2
September 24, 2016
March 29, 2018
2
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
[?]
615-654-4441
sales@specialtyh2o.com
sales@specialtyh2o.com