Contour Plus 90006349

GUDID 40301937594012

Glucose monitoring system IVD, home-use

Primary Device ID	40301937594012
NIH Device Record Key	b6154b8a-02b8-4920-89b1-cd0bc43b3887
Commercial Distribution Status	In Commercial Distribution
Brand Name	Contour Plus
Version Model Number	7594
Catalog Number	90006349
Company DUNS	080028910
Company Name	ASCENSIA DIABETES CARE US INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00301937594014 [Primary]
GS1	40301937594012 [Package] Contains: 00301937594014 Package: shipper/case [12 Units] In Commercial Distribution

NBW	System, Test, Blood Glucose, Over The Counter

Steralize Prior To Use	false
Device Is Sterile	false

40301937594012	Control Solution - Level 2. 1 x 2.5 mL.
40301937593015	Control Solution - Level 1. 1 x 2.5 mL.
40301937584501	Blood Glucose Test Strips. 50 test strips.

Mark Image Registration \| Serial	Company Trademark Application Date
CONTOUR PLUS 90000797 not registered Live/Pending	KuduPointUSA LLC 2020-06-14
CONTOUR PLUS 86167781 not registered Dead/Abandoned	Gibbons Health Products Inc. 2014-01-16
CONTOUR PLUS 74706855 not registered Dead/Abandoned	KRACO ENTERPRISES, INC. 1995-07-27