AccessGUDID - DEVICE: TRUEtrack (00021292008888)

GUDID

Device Identifier (DI) Information

Brand Name: TRUEtrack
Version or Model: TRUEtrack 25 Blood Glucose Test Strips
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRIVIDIA HEALTH, INC.

Primary DI Number: 00021292008888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 151810868 *Terms of Use

Device Description: TRUEtrack 25 Blood Glucose Test Strips

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
CGA	Glucose Oxidase, Glucose
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032657	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
Storage Environment Temperature: between 40 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c452f75-6a89-42b2-aa51-12e0d6bcee80
Public Version Date: November 22, 2021
Public Version Number: 8
DI Record Publish Date: September 20, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00311917104881	1	00021292008888	2017-07-31	Not in Commercial Distribution	Box
10050428288877	24	00050428288870		In Commercial Distribution	Case
00021292002930	1	00021292008888	2021-03-16	Not in Commercial Distribution	Box
10021292002937	24	00021292002930	2021-03-16	Not in Commercial Distribution	Case
00011822359870	1	00021292008888	2021-11-10	Not in Commercial Distribution	Box
10011822359877	24	00011822359870	2021-11-10	Not in Commercial Distribution	Case
00010939264442	1	00021292008888	2017-08-29	Not in Commercial Distribution	Box
10010939264449	24	00010939264442	2017-08-29	Not in Commercial Distribution	Case
00041220660803	1	00021292008888	2019-10-08	Not in Commercial Distribution	Box
10041220660800	24	00041220660803	2019-10-08	Not in Commercial Distribution	Case
00041415050785	1	00021292008888	2020-01-01	Not in Commercial Distribution	Box
10041415050782	24	00041415050785	2020-01-01	Not in Commercial Distribution	Case
00050428288870	1	00021292008888		In Commercial Distribution	Box
00050428421734	1	00021292008888		In Commercial Distribution	BOX
10050428421731	24	00050428421734		In Commercial Distribution	CASE
10311917104888	24	00311917104881	2017-07-31	Not in Commercial Distribution	Case