AccessGUDID - DEVICE: D.I.Controller (B297AMTDI5000)

GUDID

Device Identifier (DI) Information

Brand Name: D.I.Controller
Version or Model: A-MT-DI-5000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SPECIALITY WATER TECHNOLOGY

Primary DI Number: B297AMTDI5000
Issuing Agency: HIBCC
Commercial Distribution End Date: November 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 032528935 *Terms of Use

Device Description: DI Controller w/ Self Return Product Divert Valve, Remote Alarm Station and DI Rinse Program. Mutable 180 Seconds. Meets AAMI 2015 Standards.

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?
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

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250514	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: b6ca51ee-16db-4c91-b02d-48a89b371f7e
Public Version Date: May 19, 2026
Public Version Number: 4
DI Record Publish Date: September 24, 2016