Accu-Chek Compact Plus

GUDID 00365702701236

Accu-Chek Compact Plus Control L2 (Bio) The UDI information was not placed on the vial label due to the new kit guidance that was published.

Roche Diagnostics Operations, Inc.

Glucose IVD, control
Primary Device ID00365702701236
NIH Device Record Key1ab23cb1-b4ee-41cf-8d9a-9b16d7c7da3c
Commercial Distribution Discontinuation2018-10-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAccu-Chek Compact Plus
Version Model Number06444393001
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
GS100365702701236 [Primary]

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 Number3
Public Version Date2019-04-29
Device Publish Date2016-08-26

On-Brand Devices [Accu-Chek Compact Plus]

00365702701236Accu-Chek Compact Plus Control L2 (Bio) The UDI information was not placed on the vial label due
10365702220109ACCU-CHEK COMPACT PLUS DME KIT
10365702192109ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS
10075537490706ACCU-CHEK COMPACT PLUS CARE KIT 8/CASE

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