MICROTEK

Basic Information

• Brand Name: MICROTEK
• Primary DI: 08425921000601
• Version / Model: 1
• Company Name: Microtek Medical Inc.
• Labeler DUNS: 106908437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-29
• Public Version: 3
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: 4d242550-e8b9-4476-a122-c090d9b8e797

Device Description

7Day,Sterile,TapFilter,w/ SprayOutlet (1)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
NHV	SYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE	Gastroenterology, Urology	876.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61137	Legionella water purification filter	A device intended to remove Legionella bacteria from flowing water to reduce the risk of Legionella contamination during body washing for hygiene; it is not intended for medical washing/irrigation and is not intended for general microbial filtration. It typically consists of a plastic housing with a connector attached to the water source [e.g., a tap (faucet)] and a filtering membrane [e.g., made of polyethersulfone (PES)]; it may include a distal shower rose/directing nozzle. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18425921000615	GS1		10	In Commercial Distribution
Package	08425921000618	GS1		10	In Commercial Distribution
Primary	08425921000601	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173164	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store under normal warehouse conditions.