AccessGUDID - DEVICE: Sidekick (00021292012823)

GUDID

Device Identifier (DI) Information

Brand Name: Sidekick
Version or Model: Sidekick All-In-One Blood Glucose Monitoring System
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D4H01-83
Company Name: TRIVIDIA HEALTH, INC.

Primary DI Number: 00021292012823
Issuing Agency: GS1
Commercial Distribution End Date: August 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 151810868 *Terms of Use

Device Description: Sidekick All-In-One 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?
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 Temperature: between 36 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a4d37980-bc89-4c08-80a4-7805aff84c6e
Public Version Date: November 03, 2025
Public Version Number: 4
DI Record Publish Date: September 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10021292012707	220	00021292012700	2018-11-30	Not in Commercial Distribution	case
00021292012700	1	00021292012823	2025-08-15	Not in Commercial Distribution	box
20021292012704	125	00021292012700	2025-08-15	Not in Commercial Distribution	case