TRUEcontrol

Basic Information

• Brand Name: TRUEcontrol
• Primary DI: 00021292008369
• Version / Model: TRUEcontrol Solution Level 1
• Company Name: TRIVIDIA HEALTH, INC.
• Labeler DUNS: 151810868
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-29
• Public Version: 2
• Public Version Date: 2021-11-01
• Public Version Status: Update
• Public Device Record Key: d60378e0-8986-47a1-80cc-cc0369c63cf2

Device Description

TRUEcontrol Solution Level 1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00021292002107	GS1	box	1	In Commercial Distribution
Primary	00021292008369	GS1
Package	10021292002104	GS1	CASE	400	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032657	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: DO NOT REFRIGERATE OR FREEZE