Accu-Chek Aviva

GUDID 00365702723108

Accu-Chek Aviva Plus Retail Kit 10/case

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry
Primary Device ID00365702723108
NIH Device Record Key53e95923-9b9e-47a7-8099-05ebe0828e9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Chek Aviva
Version Model Number08350051001
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100365702723108 [Primary]
GS110365702723105 [Package]
Package: [10 Units]
In Commercial Distribution

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 Number2
Public Version Date2018-07-06
Device Publish Date2018-03-01

On-Brand Devices [Accu-Chek Aviva]

00365702725102ACCU-CHEK AVIVA PLUS METER ONLY US
10365702724102ACCU-CHEK AVIVA PLUS SAMPLE KIT 20/CASE
00365702723108Accu-Chek Aviva Plus Retail Kit 10/case
00365702544109ACCU-CHEK AVIVA MG/DL 455 US
00365702107106ACCU-CHEK AVIVA 2 LEVEL CONTROL 6/CS
00365702702394ACCU-CHEK AVIVA MG/DL 455 US NON-VA

Trademark Results [Accu-Chek Aviva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCU-CHEK AVIVA
ACCU-CHEK AVIVA
78343530 3071846 Live/Registered
Roche Diagnostics GmbH
2003-12-19

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