FDA.reportPublic FDA data

AlcoScan

Primary DI
00686091998336
Brand
AlcoScan
Company
AK GLOBALTECH CORP
Model
SM3100
Catalog number
AKG SM3100
Device description
SM3100 uses an Oxide Semiconductor sensor for high volume testing. The sensor modules MUST be replaced approx. every 400 tests or at least once per year, whichever comes first.
Published
2020-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OICBlood Alcohol Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OICBlood Alcohol Kit (Excludes Hiv Testing)Clinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00686091998336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00686091998336006860919983366860919983360686091998336

GMDN Terms#

Term, Definition table
TermDefinition
Alcohol breath analyserA portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-943-9411support@alcomate.net

Regulatory Flags#

DUNS number
119201320
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853464001126AlcoMate CoreAL6000-L2021-06-21
00853464001041AlcoMatePrestige AL6000AKG AL60002020-08-24
00853464001102AlcoMatePremium AL7000AKG AL70002020-08-24
00853464001348AlcoMateSM200AKG-SM2002020-10-06
00853464001379AlcoMateTS600AKG-TS6002020-10-06
00853464001386AlcoMateAL4000AKG-AL40002020-10-06
00853464001393AlcoMateSM600AKG-SM6002020-10-06
00853464001409AlcoMateSM3100AKG-SM31002020-10-06
00853464001416AlcoMateSM3500FCAKG-SM3500FC2020-10-06
00853464001423AlcoMateSTDMPAKG-STDMP2020-10-06
00853464001430AlcoMateSTDMP20AKG-STDMP202020-10-06
00853464001447AlcoMateSTDMP100AKG-STDMP1002020-10-06
00853464001454AlcoMateSTDMP500AKG-STDMP5002020-10-06
00853464001461AlcoMateSTDMP1000AKG-STDMP10002020-10-06
00853464001478AlcoMateINDMPAKG-INDMP2020-10-06
00853464001485AlcoMateINDMP1000AKG-INDMP10002020-10-06
00853464001089AlcoMateSM6000AKG SM60002020-08-24
00853464001119AlcoMateSM7000AKG SM70002020-08-24
00853464001355AlcoMateAlcoMate Revo TS200AKG TS2002020-08-24
10853464001420AlcoMateSTDMP50AKG-STDMP502020-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853464001126AlcoMate CoreAK Globaltech CorpOIC2021-06-21
00853464001348AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001379AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001386AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001393AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001409AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001416AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001423AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001430AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001447AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001454AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001461AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001478AlcoMateAK Globaltech CorpOIC2020-10-06
00853464001485AlcoMateAK Globaltech CorpOIC2020-10-06
10853464001420AlcoMateAK GLOBALTECH CORPOIC2020-10-06
10853464001475AlcoMateAK GLOBALTECH CORPOIC2020-10-06
20853464001427AlcoMateAK GLOBALTECH CORPOIC2020-10-06
20853464001472AlcoMateAK GLOBALTECH CORPOIC2020-10-06
00684079997852AlcoMateAK GLOBALTECH CORPOIC2020-08-31
00686091693033AlcoMateAK GLOBALTECH CORPOIC2020-08-31
00686091693040AlcoMateAK GLOBALTECH CORPOIC2020-08-31
00686091693057AlcoMateAK GLOBALTECH CORPOIC2020-08-31
00686091693064AlcoMateAK GLOBALTECH CORPOIC2020-08-31
00686091693095AlcoMateAK GLOBALTECH CORPOIC2020-08-31
00686091998664AlcoMateAK GLOBALTECH CORPOIC2020-08-31
00686091693118AlcoMateAK GLOBALTECH CORPOIC2020-08-27
00686091693125AlcoMateAK GLOBALTECH CORPOIC2020-08-27
00686162990924AlcoMateAK GLOBALTECH CORPOIC2020-08-27
00687398972906AlcoMateAK GLOBALTECH CORPOIC2020-08-27
00687398972913AlcoMateAK GLOBALTECH CORPOIC2020-08-27