AccessGUDID - DEVICE: AlcoMate (00853464001089)

GUDID

Device Identifier (DI) Information

Brand Name: AlcoMate
Version or Model: SM6000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AKG SM6000
Company Name: AK Globaltech Corp

Primary DI Number: 00853464001089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119201320 *Terms of Use

Device Description: The First Device featuring PRISM Technology. Global patent including US Patent No. US 7.841.224 B2 & US 8.250.900 B2, Accuracy: +/- 0.01 at 0.10 g/dL (%BAC), Sensor module must be replaced every 200 tests or at least once yearly, whichever comes first.

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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
Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f25c6c18-470c-49d8-9f12-9b6700df0dcf
Public Version Date: June 09, 2023
Public Version Number: 3
DI Record Publish Date: August 24, 2020