Accutest Breath Alcohol Detector

Basic Information

• Brand Name: Accutest Breath Alcohol Detector
• Primary DI: 10763924095213
• Version / Model: DS95AC220
• Company Name: JANT PHARMACAL CORPORATION
• Labeler DUNS: 797393659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 0ee0a99f-ea6e-4012-b222-8c2a45eed482

Device Description

Breath Alcohol Detector, .02 % BAC.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	862.3050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62049	Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10763924095213	GS1
Unit of Use	00763924095216	GS1

Premarket Submissions

Submission Number	Supplement Number
K093143	000