AlcoMate AKG-SM200

GUDID 00853464001348

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.

AK GLOBALTECH CORP

Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser Alcohol breath analyser
Primary Device ID00853464001348
NIH Device Record Keycb43783b-521e-4d0e-89dd-2c1bc1cd0dbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlcoMate
Version Model NumberSM200
Catalog NumberAKG-SM200
Company DUNS119201320
Company NameAK GLOBALTECH CORP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net
Phone201-943-9411
Emailsupport@alcomate.net

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.

Device Identifiers

Device Issuing AgencyDevice ID
GS100853464001348 [Primary]

FDA Product Code

OICBlood Alcohol Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-14
Device Publish Date2020-10-06

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00686091999371Fuel-Cell technology provides you with increased precision and accuracy, and also less worry wit
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00687398972937lcoMate Core Model AL6000-L Alcohol Tester is a good choice for consumers who would prefer price
00687398972920The AccuCell provides superior, high-capacity testing, but without the PRISM Technology availabl
00687398972913AlcoMate TS600 is an evidential breathalyzer (EBT) with advanced fuel cell technology. TS600 is
00687398972906The AL2500 breathalyzer is a perfect entry-level device with the convenience of ultra-light port
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00686091693095AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00686091693064AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00686091693057AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00686091693040AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00686091693033AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00684079997852AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
20853464001472AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
20853464001427AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
10853464001475AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
10853464001420AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001485AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001478AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001461AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001454AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001447AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001430AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001423AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from o
00853464001416Fuel-Cell technology provides you with increased precision and accuracy, and also less worry wit
00853464001409Fuel-Cell technology provides you with increased precision and accuracy, and also less worry wit
00853464001393Fuel-Cell technology provides you with increased precision and accuracy, and also less worry wit
00853464001386AlcoMate AL4000 FUEL CELL Coin-Operated Vending-Type Breathalyzer with Pre-Calibrated Replaceabl
00853464001379AlcoMate TS600 is an evidential breathalyzer (EBT) with advanced fuel cell technology. TS600 is
00853464001348Fuel-Cell technology provides you with increased precision and accuracy, and also less worry wit
00853464001102The AlcoMate Premium breathalyzer features patented PRISM Technology, which eliminates two funda
00853464001041AlcoMate Prestige AL6000 is the original breath tester that introduced pre-calibrated replaceabl

Trademark Results [AlcoMate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALCOMATE
ALCOMATE
88788057 not registered Live/Pending
AK GLOBALTECH CORP.
2020-02-06
ALCOMATE
ALCOMATE
77388559 3495802 Live/Registered
AK GLOBALTECH CORP.
2008-02-05

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