DEVICE: POST-TREAT, .03 30", 208V (PS0155)

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Device Record History
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Device Identifier (DI) Information
POST-TREAT, .03 30", 208V
WM-PST-303-OO-1GJ
In Commercial Distribution
WM-PST-303-OO-1GJ
BETTER WATER, LLC
PS0155
HIBCC

1
055252159 *Terms of Use
Wall-mounted post-treatment for water purification for dialysis applications. Includes one .03 30" filter, particulate filter, DI header, 1 pump, and divert-to-drain. 208V.
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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© 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?
44344 Combination water purification system
An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.
Active false
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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 [?]
K920186 000
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
e989d779-8fa3-45b6-834b-77489d8957f7
November 21, 2024
1
November 13, 2024
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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
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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