Accu-Chek Guide

GUDID 00365702609105

ACCU-CHEK GUIDE MG/DL METER 923 (US)

Roche Diagnostics Operations, Inc.

Glucose analyser IVD, home-use
Primary Device ID00365702609105
NIH Device Record Key8652adf3-2a0e-4467-add4-5706a74318e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Guide
Version Model Number07398794001
Company DUNS141608724
Company NameRoche Diagnostics Operations, 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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100365702609105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-28

On-Brand Devices [Accu-Chek Guide]

00365702729100Accu-Chek Guide Retail Kit FCN mg/dl US
10365702728100Accu-Chek Guide Sample Kit FCN mg/dl US
10365702726106Accu-Chek Guide Mail Order 50 ct
00365702719101Accu-Chek Guide 50ct HN 36/cs
00365702712102ACCU-CHEK GUIDE 100CT STRIP 24/CS
00365702710108Accu-Chek Guide 25ct Strip 36/cs
00365702702066ACCU-CHEK GUIDE METER ONLY MG/DL US
00365702702042ACCU-CHEK GUIDE RETAIL KIT MG/DL
10365702702032ACCU-CHEK GUIDE SAMPLE KIT MG/DL
00365702701977ACCU-CHEK GUIDE 10CT STRIP 36/CS
00365702701953ACCU-CHEK GUIDE 50CT STRIP 36/CS
00365702701908VIAL LBLD 10CT STRIP ACCU-CHEK GUIDE
00365702688100ACCU-CHEK GUIDE 2-LEVEL CONTROLS US
00365702609105ACCU-CHEK GUIDE MG/DL METER 923 (US)

Trademark Results [Accu-Chek Guide]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCU-CHEK GUIDE
ACCU-CHEK GUIDE
86308216 5256607 Live/Registered
ROCHE DIABETES CARE GMBH
2014-06-12
ACCU-CHEK GUIDE
ACCU-CHEK GUIDE
85453493 not registered Dead/Abandoned
Roche Diagnostics GmbH
2011-10-21
ACCU-CHEK GUIDE
ACCU-CHEK GUIDE
77280757 not registered Dead/Abandoned
Roche Diagnostics GmbH
2007-09-17

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