FDA.reportPublic FDA data

AlcoMate

Primary DI
00853464001089
Brand
AlcoMate
Company
AK Globaltech Corp
Model
SM6000
Catalog number
AKG SM6000
Device description
The First Device featuring PRISM Technology. Global patent including US Patent No. US 7.841.224 B2 & US 8.250.900 B2, Accuracy: +/- 0.01 at 0.10 g/dL (%BAC), Sensor module must be replaced every 200 tests or at least once yearly, whichever comes first.
Published
2020-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJZDevices, Breath Trapping, AlcoholClinical Toxicology1
OICBlood Alcohol Kit (Excludes Hiv Testing)Clinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853464001089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853464001089008534640010898534640010890853464001089

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
Premarket exempt
true
Serial number
true
Expiration date on label
true

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
00853464001119AlcoMateSM7000AKG SM70002020-08-24
00853464001355AlcoMateAlcoMate Revo TS200AKG TS2002020-08-24
10853464001420AlcoMateSTDMP50AKG-STDMP502020-10-06
10853464001475AlcoMateINDMP100AKG-INDMP1002020-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B90112SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2025-08-19
B90110SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2023-09-23
B90111SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2023-09-23
G354AAB08201AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB08402AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15201AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15402AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354CCP024103CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP042001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP044103CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP082001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP084103CheckpointAlcopro Inc.DJZ2022-09-22
G354AAB08202AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB08400AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15202AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354AAB15400AlcoBreath TubeAlcopro Inc.DJZ2022-09-22
G354CCP022001CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP024100CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP042002CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP044104CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP082002CheckpointAlcopro Inc.DJZ2022-09-22
G354CCP084104CheckpointAlcopro Inc.DJZ2022-09-22
B90108SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2022-06-23
B90109SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2022-06-23
B90106SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-12-08
B90107SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-12-08
00853464001126AlcoMate CoreAK Globaltech CorpOIC2021-06-21
00853464001126AlcoMate CoreAK Globaltech CorpDJZ2021-06-21
B90101SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90102SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07