Accutest Breath Alcohol Detector

Primary DI
10763924095213
Brand
Accutest Breath Alcohol Detector
Company
JANT PHARMACAL CORPORATION
Model
DS95AC220
Device description
Breath Alcohol Detector, .02 % BAC.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DJZDevices, Breath Trapping, Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJZDevices, Breath Trapping, AlcoholClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093143000MISSION BREATH ALCOHOL DETECTORACON Laboratories, Inc.2010-01-28DJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924095213PrimaryGS10
00763924095216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392409521310763924095213
00763924095216007639240952167639240952160763924095216

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, rapid colorimetric, clinicalA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797393659
Device count
20
Lot or batch
true
Expiration date on label
true

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