AccessGUDID - DEVICE: Zeolite Filter Tank (B297KAMT7J543070)

GUDID

Device Identifier (DI) Information

Brand Name: Zeolite Filter Tank
Version or Model: K-A-MT-7J54-307
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPECIALITY WATER TECHNOLOGY

Primary DI Number: B297KAMT7J543070
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 032528935 *Terms of Use

Device Description: Zeolite Filter Tank (7 cu ft), 21" x 62", Fleck SXT 2815, 35 DLFC

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?
35431	Charcoal water purification filter	A device containing charcoal designed to filter primarily soluble organic components from flowing water. It is typically filled with activated carbon to adsorb low-molecular weight organics such as chloramines, a substance that is frequently used in tap water sources as a bactericidal agent. The device is frequently used to filter tap water intended for haemodialysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 7b9b6272-9e10-4f5f-85ba-e74cb42ad54f
Public Version Date: March 09, 2020
Public Version Number: 1
DI Record Publish Date: February 28, 2020