BEUDAMED
    Product Code: DJZ FDA class 1 21 CFR 862.3050

    Devices, Breath Trapping, Alcohol

    Clinical Toxicology

    Breath Trapping Devices for Alcohol are collection devices designed to capture and preserve exhaled breath samples for subsequent laboratory analysis of ethanol content, supporting forensic and clinical toxicology investigations of alcohol exposure. This device is classified as FDA Class 1, indicating low risk, and is subject only to general controls without premarket notification requirements. It is regulated under 21 CFR 862.3050 within the Clinical Toxicology specialty.

    View on FDA
    510(k)s
    28
    FEI Numbers
    40
    Registration Numbers
    40
    Unique Applicants
    20
    Years Active
    12

    Basic Information

    Product Code
    DJZ
    Device Class
    FDA class 1
    Regulation Number
    862.3050
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 28 510(k) clearances via K numbers.

    K Number Device Name
    K160613 Soberlink Cellular Device and Sober Sky Web Portal
    K123470 PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
    K110614 PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
    K102225 ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
    K102338 BREATHSCN PRO
    K100879 CONTRALCO
    K093143 MISSION BREATH ALCOHOL DETECTOR
    K091714 ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
    K090766 LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
    K082080 ALCO TUBE PLUS
    K090067 BACTRACK SELECT BREATHALYZER, MODEL S80
    K083801 BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
    K082086 KEY RING ALCOHOL BREATHALYZER
    K081855 IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
    K080848 ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
    K063443 DRAEGER ALCOTEST 6510
    K072953 REDLINE ALCOHOL BREATH TESTER
    K071067 BACTRACK LCD ALCOHOL DETECTOR
    K062545 RMI LCD ALCOHOL DETECTOR
    K062971 BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
    K061922 BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
    K060343 BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
    K060761 BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
    K052448 POCKET BREATHALYZER. CONNECTABLES
    K053332 BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
    K052804 BREATHKEY MODEL G10/BREATHKEY MODEL G30X
    K043188 ALCOHAWK PRECISION
    K041334 ALCOMATE, MODEL CA2000

    FEI Numbers

    This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.