AlcoMate

Basic Information

• Brand Name: AlcoMate
• Primary DI: 00853464001430
• Version / Model: STDMP20
• Catalog Number: AKG-STDMP20
• 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: 0ffeb83e-a671-487b-bc06-1f807bd4c0e8

Device Description

AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.

Device Characteristics

• Single Use: Yes
• 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	00853464001430	GS1

Customer Contacts

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