AccessGUDID - DEVICE: Easy Talk Blood Glucose Testing Strips 25ct (00891237001485)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Talk Blood Glucose Testing Strips 25ct
Version or Model: 8818
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1485
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00891237001485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: 25 ct bottle Blood Glucose Testing Strips for use with Easy Talk or Easy Plus II monitoring systems

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 [?]
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
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: e51e7dc1-0560-4cf6-b6b5-97e2994c7a09
Public Version Date: April 13, 2026
Public Version Number: 4
DI Record Publish Date: May 03, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10891237001482	2	00891237001485	In Commercial Distribution	Box
20891237001489	20	10891237001482	In Commercial Distribution	Inner Case
30891237001486	20	20891237001489	In Commercial Distribution	Outer Case