TRUE FOCUS

GUDID 00021292005726

TRUE FOCUS Control Solution Level 3

TRIVIDIA HEALTH, INC.

Glucose IVD, control
Primary Device ID00021292005726
NIH Device Record Key44a33b4a-ed02-41ed-8ea0-a516843e370e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUE FOCUS
Version Model NumberTRUE FOCUS Control Solution Level 3
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 Perscriptiontrue
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT REFRIGERATE OR FREEZE

Device Identifiers

Device Issuing AgencyDevice ID
GS100021292005726 [Package]
Contains: 00021292008444
Package: BOX [1 Units]
In Commercial Distribution
GS100021292008444 [Primary]
GS110021292005723 [Package]
Package: CASE [24 Units]
In Commercial Distribution

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 Date2021-03-08
Device Publish Date2021-02-26

On-Brand Devices [TRUE FOCUS]

10311917188062Walgreens TRUE FOCUS Self Monitoring Blood Glucose Meter box
00021292005726TRUE FOCUS Control Solution Level 3
00021292005719TRUE FOCUS Control Solution Level 2
00021292005702TRUE FOCUS Control Solution Level 1

Trademark Results [TRUE FOCUS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUE FOCUS
TRUE FOCUS
90721380 not registered Live/Pending
Skytron, LLC
2021-05-19
TRUE FOCUS
TRUE FOCUS
87910142 not registered Live/Pending
cGreen
2018-05-07
TRUE FOCUS
TRUE FOCUS
87872813 5611738 Live/Registered
Alliance Benefit Group of Michigan, Inc.
2018-04-11
TRUE FOCUS
TRUE FOCUS
86702156 5296927 Live/Registered
TRIVIDIA HEALTH, INC.
2015-07-23
TRUE FOCUS
TRUE FOCUS
86702135 5296926 Live/Registered
TRIVIDIA HEALTH, INC.
2015-07-23
TRUE FOCUS
TRUE FOCUS
85505789 not registered Dead/Abandoned
Nipro Diagnostics, Inc.
2011-12-29
TRUE FOCUS
TRUE FOCUS
85505769 not registered Dead/Abandoned
Nipro Diagnostics, Inc.
2011-12-29
TRUE FOCUS
TRUE FOCUS
76645808 3152645 Dead/Cancelled
SILAGY, HOWARD
2005-08-29

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