DEVICE: Portable R.O. Cart For Dialysis (B297APT5500CRTA0)

Device Identifier (DI) Information

Portable R.O. Cart For Dialysis
A-PT-5500-CRT-A
In Commercial Distribution

SPECIALITY WATER TECHNOLOGY
B297APT5500CRTA0
HIBCC

1
032528935 *Terms of Use
Portable RO Cart for Dialysis. Dual Carbon Block Assy w/ Pre-Filter.
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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
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.
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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

c8db5fc2-7c61-4e3f-bc3c-f3cf67343aba
March 29, 2018
2
October 13, 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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