FDA.reportPublic FDA data

SOBERLINK

Primary DI
B90105
Brand
SOBERLINK
Company
SOBERLINK HEALTHCARE LLC
Model
SOBERLINK GSM1 REFURB - 05
Published
2021-04-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K160613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160613000Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLC2016-07-14DJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B90105PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079871438
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B90112SOBERLINKSOBERLINK 7.0 2025-08-19
B90110SOBERLINKSOBERLINK CELLULAR CATM 2023-09-23
B90111SOBERLINKSOBERLINK CELLULAR CATM REFURB2023-09-23
B90108SOBERLINKSOBERLINK CONNECT ST - 082022-06-23
B90109SOBERLINKSOBERLINK Connect ST REFURB2022-06-23
B90106SOBERLINKSOBERLINK LTE - 062021-12-08
B90107SOBERLINKSOBERLINK LTE REFURB- 072021-12-08
B90101SOBERLINKSOBERLINK Connect - 012021-04-07
B90102SOBERLINKSOBERLINK GSM2 - 022021-04-07
B90103SOBERLINKSOBERLINK Connect REFURB - 032021-04-07
B90104SOBERLINKSOBERLINK GSM2 REFURB - 042021-04-07
B901CONNECT0SOBERLINKCONNECT2020-05-07
B901CONNECTREFURB0SOBERLINKSOBERLINK CONNECT REFURB2020-05-07
B901GSM1REFURB0SOBERLINKSOBERLINK GSM1 REFURB2020-05-07
B901GSM20SOBERLINKSOBERLINK GSM22020-05-07
B901GSM2REFURB0SOBERLINKSOBERLINK GSM2 REFURB2020-05-07

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 CorpDJZ2021-06-21
B90101SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90102SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07
B90103SOBERLINKSOBERLINK HEALTHCARE LLCDJZ2021-04-07