SOBERLINK

Basic Information

• Brand Name: SOBERLINK
• Primary DI: B90112
• Version / Model: SOBERLINK 7.0
• Company Name: SOBERLINK HEALTHCARE LLC
• Labeler DUNS: 079871438
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-19
• Public Version: 1
• Public Version Date: 2025-08-27
• Public Version Status: New
• Public Device Record Key: 73b4d7f5-2e91-40bb-b196-7bdcfa8983d8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
36041	Alcohol breath analyser	A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B90112	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K160613	000