Zeolite Filter Tank

Basic Information

• Brand Name: Zeolite Filter Tank
• Primary DI: B297KAMT7K554100
• Version / Model: K-A-MT-7K55-410
• Company Name: SPECIALITY WATER TECHNOLOGY
• Labeler DUNS: 032528935
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-06
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 8f385b6d-dc80-4f14-bf8c-e49fc7c35618

Device Description

Zeolite Filter Tank (10cu ft), 24" x 72", Fleck SXT 2815, 45 DLFC

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIP	Subsystem, Water Purification	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B297KAMT7K554100	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]