ACCU-CHEK AVIVA PLUS 06908217001

GUDID 10365702407104

ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C

Roche Diagnostics Operations, Inc.

Glucose IVD, reagent
Primary Device ID10365702407104
NIH Device Record Key990b9d38-a91c-4f18-bee4-49dcb3e94fb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCU-CHEK AVIVA PLUS
Version Model Number06908217001
Catalog Number06908217001
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 Batchtrue
Serial Numberfalse
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
GS100365702407107 [Primary]
GS110365702407104 [Package]
Contains: 00365702407107
Package: [36 Units]
In Commercial Distribution

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-26

On-Brand Devices [ACCU-CHEK AVIVA PLUS]

00365702700932VIAL LBLD 10CT STRIP AC AVIVA PLUS BRK
00365702445109ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE
10365702438108ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS
00365702437104ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C
10365702436104ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS
10365702408101ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C
10365702407104ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C
00365702405103ACCU-CHEK AVIVA PLUS 10CT STRIP BRK
00365702134102ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE
00365702102101ACCU-CHEK AVIVA PLUS METER-ONLY
00365702101104ACCU-CHEK AVIVA PLUS RETAIL KIT 8/CASE

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