AccessGUDID - DEVICE: Easy Step Blood Glucose Monitoring System (00891237001188)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Step Blood Glucose Monitoring System
Version or Model: T5D4-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1188
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00891237001188
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 Step test strips Test Sample:Capillary Whole Blood from Fingertip, Palm and Forearm Sample Volume:>0.5 uL Measuring Unit:mg/dL or mmol/L Measuring Range:20 - 600 mg/dL (1.1 - 33.3 mmol/L) Test Time:5 sec Memory Capacity:300 most recent results Average:7/14/30 days average results External Output: USB data port Power supply:One 3-Volt lithium battery (CR-2032) Battery Life:Approximately 1000 tests Dimension and Weight:79 x 60 x17 mm ; 55 g

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 [?]
K090629	000

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
Special Storage Condition, Specify: Keep meter within 39-86 oF (4-30 oC) and out of direct sunlight
Handling Environment Humidity: between 10 and 90 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: ad3fa71e-6906-42f6-8d2b-2c4cdd0f03ff
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: May 01, 2016