ACCU-CHEK COMPACT PLUS

GUDID 10075537490706

ACCU-CHEK COMPACT PLUS CARE KIT 8/CASE

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry
Primary Device ID10075537490706
NIH Device Record Key3399ffe1-79b4-4c2d-a1e9-6adb1f5e7eef
Commercial Distribution Discontinuation2019-12-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameACCU-CHEK COMPACT PLUS
Version Model Number03149137001
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
GS100075537490709 [Primary]
GS110075537490706 [Package]
Contains: 00075537490709
Package: [8 Units]
Discontinued: 2019-12-23
Not in Commercial Distribution

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-24
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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