TRUE FOCUS UE4001-00

GUDID 10311917188062

Walgreens TRUE FOCUS Self Monitoring Blood Glucose Meter box

TRIVIDIA HEALTH, INC.

Glucose monitoring system IVD, home-use
Primary Device ID10311917188062
NIH Device Record Key4de9114c-3c1f-460b-9bb4-56019aa89b43
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUE FOCUS
Version Model NumberTRUE FOCUS Self Monitoring Blood Glucose Meter
Catalog NumberUE4001-00
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100021292007744 [Direct Marking]
GS100311917188065 [Primary]
GS110311917188062 [Package]
Contains: 00311917188065
Package: CASE [12 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-12
Device Publish Date2017-06-21

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.