Accu-Chek Combo 05458544001

GUDID 04015630883806

Accu-Chek Combo Kit mg US/en

Roche Diabetes Care GmbH

Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system Ambulatory insulin infusion pump/blood glucose analyser system
Primary Device ID04015630883806
NIH Device Record Key8f14dc4b-b546-4831-86cd-f28c37fd66be
Commercial Distribution Discontinuation2016-09-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAccu-Chek Combo
Version Model Number05458544001
Catalog Number05458544001
Company DUNS313212471
Company NameRoche Diabetes Care GmbH
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630883806 [Primary]

FDA Product Code

LZGPump, Infusion, Insulin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-07-25
Device Publish Date2016-08-25

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