AlcoMate

Basic Information

• Brand Name: AlcoMate
• Primary DI: 00853464001379
• Version / Model: TS600
• Catalog Number: AKG-TS600
• Company Name: AK Globaltech Corp
• Labeler DUNS: 119201320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-06
• Public Version: 3
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: 9956f4bd-c03e-4125-a5e6-4617939e35be

Device Description

AlcoMate TS600 is an evidential breathalyzer (EBT) with advanced fuel cell technology. TS600 is a highly-upgraded professional breathalyzer for measuring alcohol in human breath. Test results can be stored on TS600 or printed out the data through wired or wireless (optional) connecting with mobile printer.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
OIC	Blood Alcohol Kit (Excludes Hiv Testing)	Clinical Toxicology	862.3040	2
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	862.3050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36041	Alcohol breath analyser	A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853464001379	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit