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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AlcoMate Prestige AL6000 is the original breath tester that introduced pre-calibrated replaceable sensor module technology to the market. Pre-calibrated replaceable sensor modules eliminate the need for traditional mail-back calibration service that is required of all other typical breathalyzers.
AK Globaltech Corp
Prestige AL6000
In Commercial Distribution

  • 00853464001041 ()
AKG AL6000

  • Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK CELLULAR CATM
In Commercial Distribution

  • B90110 ()


  • Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK CONNECT ST - 08
In Commercial Distribution

  • B90108 ()


  • Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK LTE - 06
In Commercial Distribution

  • B90106 ()


  • Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK GSM1 REFURB - 05
Not in Commercial Distribution

  • B90105 ()


  • Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK GSM2 - 02
In Commercial Distribution

  • B90102 ()


  • Alcohol breath analyser
No Description
SOBERLINK HEALTHCARE LLC
SOBERLINK Connect - 01
In Commercial Distribution

  • B90101 ()


  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP08
In Commercial Distribution

  • G354CCP084104 ()
  • G354CCP084103 ()
  • G354CCP084100 ()
CCP08410

  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP08
In Commercial Distribution

  • G354CCP082002 ()
  • G354CCP082001 ()
  • G354CCP082003 ()
  • G354CCP082000 ()
CCP08200

  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP04
In Commercial Distribution

  • G354CCP044104 ()
  • G354CCP044103 ()
  • G354CCP044100 ()
CCP04410

  • Alcohol breath analyser
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