AccessGUDID - DEVICE: Easy@Home Fuel Cell Breathalyzer (00850003180328)

GUDID

Device Identifier (DI) Information

Brand Name: Easy@Home Fuel Cell Breathalyzer
Version or Model: EAT-05FL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EASY HEALTHCARE CORPORATION

Primary DI Number: 00850003180328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080278407 *Terms of Use

Device Description: No description.

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):	Yes
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
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: f4e63a44-14af-4d7f-bec4-36198796e5d1
Public Version Date: August 08, 2019
Public Version Number: 1
DI Record Publish Date: July 31, 2019