AccessGUDID - DEVICE: Easy Step Blood Glucose Test Strips 50ct (00891237001195)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Step Blood Glucose Test Strips 50ct
Version or Model: T5D2-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1195
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00891237001195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: 50ct box of Easy Step blood glucose test strips for use with Easy Step blood glucose monitoring system

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:	Yes
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?
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	Glucose Oxidase, Glucose
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: Store at room temperature between 46-86 oF (8-30 oC)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54af7c3b-fb14-42de-8576-0267df64ca0a
Public Version Date: April 13, 2026
Public Version Number: 5
DI Record Publish Date: May 03, 2016