AgaMatrix

GUDID 10385541002001

Test Strips, AgaMatrix, Jazz, 10CT

AGAMATRIX, INC.

Glucose monitoring system IVD, home-use
Primary Device ID10385541002001
NIH Device Record Key52031f67-b45b-47a6-aa46-c11f53ed8dae
Commercial Distribution StatusIn Commercial Distribution
Brand NameAgaMatrix
Version Model Number8000-10474
Company DUNS156756129
Company NameAGAMATRIX, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone18669064197
Emailcustomerservice@agamatrix.com
Phone18669064197
Emailcustomerservice@agamatrix.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100385541001908 [Primary]
GS110385541002001 [Package]
Contains: 00385541001908
Package: Shipper [24 Units]
In Commercial Distribution
GS120385541002909 [Package]
Package: Outer Shipper [20 Units]
In Commercial Distribution
GS180385541001904 [Unit of Use]

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-03
Device Publish Date2016-07-11

On-Brand Devices [AgaMatrix]

20385544940017System Kit, Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL
00385544025017System Kit, Blood Glucose Meter, Agamatrix, AMP, mg/dL
20385543764027Control Solution, AgaMatrix, Combo Normal and High
20385542649011System Kit, Blood Glucose Meter, AgaMatrix, Presto, mg/dL
10385541002605System Kit, Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL
00385541002509Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL
10385541002407Test Strips, AgaMatrix, Jazz, 50CT
10385541002001Test Strips, AgaMatrix, Jazz, 10CT
20385541000806System Kit, Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL
10385542661016Blood Glucose Meter, AgaMatrix, Presto, mg/dL
10385541000700Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL

Trademark Results [AgaMatrix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AGAMATRIX
AGAMATRIX
85314199 4226717 Live/Registered
AgaMatrix, Inc.
2011-05-06
AGAMATRIX
AGAMATRIX
78374141 3412624 Live/Registered
AgaMatrix, Inc.
2004-02-25

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