AccessGUDID - DEVICE: Easy Talk/Plus II Glucose Test Strips (00850027494227)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Talk/Plus II Glucose Test Strips
Version or Model: ET-PIISTR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00850027494227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: Box of 50 Glucose Strips compatible with Easy Talk Glucose Monitor and Easy Plus II Glucose Monitor

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

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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

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100560	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7557e70f-7513-4ea4-af95-9228c5a2e1e3
Public Version Date: June 24, 2024
Public Version Number: 1
DI Record Publish Date: June 14, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
10850027494224	2	00850027494227	In Commercial Distribution	Box
20850027494221	20	10850027494224	In Commercial Distribution	Inner Carton
30850027494228	20	20850027494221	In Commercial Distribution	Case