ACCU-CHEK COMPACT PLUS

GUDID 10365702220109

ACCU-CHEK COMPACT PLUS DME KIT

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry Glucose IVD, kit, spectrophotometry
Primary Device ID10365702220109
NIH Device Record Keyeef8e8c5-2201-4ab3-86bf-877036f4b50c
Commercial Distribution Discontinuation2018-07-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameACCU-CHEK COMPACT PLUS
Version Model Number05177294001
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
GS100365702220102 [Primary]
GS110365702220109 [Package]
Contains: 00365702220102
Package: [8 Units]
Discontinued: 2018-07-03
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 Date2019-04-29
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

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