AccessGUDID - DEVICE: SDI EXCHANGE TANK 3.6 CU/FT MIXED BED RESIN (B486W5TDIMB10360FSQR0)

GUDID

Device Identifier (DI) Information

Brand Name: SDI EXCHANGE TANK 3.6 CU/FT MIXED BED RESIN
Version or Model: W5TDIMB10360FSQR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Evoqua Water Technologies Corp.

Primary DI Number: B486W5TDIMB10360FSQR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079427087 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14435	Deionization water purification system	An assembly of mains electricity (AC-powered) devices that includes ion exchange columns designed to remove unwanted chemical contaminants from water. This system purifies water principally by removing negative and positive ions of minerals (e.g., sodium, calcium, iron, copper) using filtration through a combination of anionic and cationic resins (also known as demineralization); it facilitates the production of "soft" water.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K994279	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22236f91-66f4-4c1d-bef2-abbd650300df
Public Version Date: May 30, 2024
Public Version Number: 1
DI Record Publish Date: May 22, 2024