DEVICE: Shelco Filtration System (B297APT506110050)

Device Identifier (DI) Information

Shelco Filtration System
A-PT-5061-100-5
In Commercial Distribution

SPECIALITY WATER TECHNOLOGY
B297APT506110050
HIBCC

1
032528935 *Terms of Use
Pre-RO 1" Shelco Housing Assembly, Holds (5) 20” Filters, 1-Micron, With Bypass Valves
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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
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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FDA Product Code

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Product Code Product Code Name
FIP Subsystem, Water Purification
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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
No Device Sizes
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Device Record Status

c55f7080-78d2-48ce-943c-6357f0acd10d
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

[?]
615-654-4441
sales@specialtyh2o.com
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