AccessGUDID - DEVICE: AlcoMate (00853464001478)

GUDID

Device Identifier (DI) Information

Brand Name: AlcoMate
Version or Model: INDMP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AKG-INDMP
Company Name: AK Globaltech Corp

Primary DI Number: 00853464001478
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119201320 *Terms of Use

Device Description: AlcoMate's breathalyzer mouthpieces have been designed to ensure accuracy. Differentiated from other breathalyzer mouthpieces, our one-way flow technology provides the most accurate results. For the best results, please use genuine AlcoMate Breathalyzer Mouthpieces. Fits for all AlcoMate brand breathalyzers, Revo TS200, Premium AL7000, Prestige AL6000, AccuCell AL9000, Core.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36041	Alcohol breath analyser	A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIC	Blood Alcohol Kit (Excludes Hiv Testing)
DJZ	Devices, Breath Trapping, Alcohol

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 42b1723d-a04d-4b31-b8e4-212f6f9c621e
Public Version Date: June 09, 2023
Public Version Number: 3
DI Record Publish Date: October 06, 2020