DEVICE: AmeriWater Water Purification System for Hemodialysis (00817927020338)
Device Identifier (DI) Information
AmeriWater Water Purification System for Hemodialysis
Complete System
In Commercial Distribution
AMERIWATER, LLC
Complete System
In Commercial Distribution
AMERIWATER, LLC
AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis.
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? |
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14437 | Reverse-osmosis water purification system |
An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.
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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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K991519 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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High-level Disinfectant |
Peracetic Acid |
Moist Heat or Steam 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
0f397fdc-4ac8-41ca-b433-5c4496bb481d
June 15, 2023
1
June 07, 2023
June 15, 2023
1
June 07, 2023
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
[?]
No Customer Contact currently defined