AccessGUDID - DEVICE: Easy Plus II Blood Glucose Monitoring System (00891237001652)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Plus II Blood Glucose Monitoring System
Version or Model: 6276
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1652
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00891237001652
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: Blood Glucose Testing Monitor to be used with Easy Plus II or Easy Talk test strips Test: Glucose Sample: Whole Blood Principle of the test method: Amperometric, glucose oxidase Test sites: Fingertip, forearm Measurement time: 6 seconds Code required: No code device Measurement Range: 20~600 mg/dL (1.1~33.3mmol/L ). Batteries: 2 x AAA 1.5 V Alkaline 24A LR03

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?
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2cabc874-6b45-476e-beab-bdffd650133e
Public Version Date: October 03, 2019
Public Version Number: 4
DI Record Publish Date: May 01, 2016