TRUEcontrol

GUDID 00021292008376

TRUEcontrol Solution Level 2

TRIVIDIA HEALTH, INC.

Glucose IVD, control
Primary Device ID00021292008376
NIH Device Record Key5725df5e-58d5-4854-ace6-bd3c07b51bec
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUEcontrol
Version Model NumberTRUEcontrol Solution Level 2
Company DUNS151810868
Company NameTRIVIDIA HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com
Phone+1(800)803-6025
Emailcustomercare@trividiahealth.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE

Device Identifiers

Device Issuing AgencyDevice ID
GS100021292008376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-08
Device Publish Date2021-01-29

On-Brand Devices [TRUEcontrol]

00021292002091TRUEcontrol Solution Level 0
00021292008376TRUEcontrol Solution Level 2
00021292002107TRUEcontrol Solution Level 1

Trademark Results [TRUEcontrol]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUECONTROL
TRUECONTROL
88644691 not registered Live/Pending
RHA Technologies Ltd
2019-10-07
TRUECONTROL
TRUECONTROL
88045085 not registered Dead/Abandoned
Mediashift Technologies, Inc.
2018-07-19
TRUECONTROL
TRUECONTROL
86170835 4683768 Live/Registered
TRIVIDIA HEALTH, INC.
2014-01-21
TRUECONTROL
TRUECONTROL
85229781 not registered Dead/Abandoned
Savant Systems LLC
2011-01-31
TRUECONTROL
TRUECONTROL
78520242 3041351 Dead/Cancelled
Rendition Networks, Inc.
2004-11-19
TRUECONTROL
TRUECONTROL
78025355 not registered Dead/Abandoned
Abbott Laboratories
2000-09-11
TRUECONTROL
TRUECONTROL
77365927 3515317 Dead/Cancelled
NIPRO DIAGNOSTICS, INC.
2008-01-07
TRUECONTROL
TRUECONTROL
77172892 3368510 Dead/Cancelled
NIPRO DIAGNOSTICS, INC.
2007-05-04
TRUECONTROL
TRUECONTROL
76481894 not registered Dead/Abandoned
Rendition Networks, Inc.
2003-01-13

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