AccessGUDID - DEVICE: TRUEcontrol (00021292008383)

GUDID

Device Identifier (DI) Information

Brand Name: TRUEcontrol
Version or Model: TRUEcontrol Solution Level 0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRIVIDIA HEALTH, INC.

Primary DI Number: 00021292008383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151810868 *Terms of Use

Device Description: TRUEcontrol Solution Level 0

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:	No
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?
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

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
Handling Environment Temperature: between 36 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: DO NOT REFRIGERATE OR FREEZE

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8668f78d-926d-4a4a-b6c5-fd2102a01a8c
Public Version Date: November 01, 2021
Public Version Number: 2
DI Record Publish Date: January 29, 2021