Accu-Chek Link Assist 04530039001

GUDID 04015630048601

Accu-Chek Link Assist

Roche Diabetes Care GmbH

Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer Insulin infusion cannula introducer
Primary Device ID04015630048601
NIH Device Record Keyc2b0bcf3-690a-4e9f-b7a7-f66d63f5dda7
Commercial Distribution Discontinuation2022-07-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAccu-Chek Link Assist
Version Model Number04530039001
Catalog Number04530039001
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630048601 [Primary]

FDA Product Code

KZHIntroducer, Syringe Needle

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 Date2016-08-12

Devices Manufactured by Roche Diabetes Care GmbH

04015630046713 - Accu-Chek Rapid-D2023-07-25 Accu-Chek Rapid-D 6/80 15+5+5pcs
04015630048601 - Accu-Chek Link Assist2023-07-25Accu-Chek Link Assist
04015630048601 - Accu-Chek Link Assist2023-07-25 Accu-Chek Link Assist
04015630049929 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 8/60 10pcs
04015630049936 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 8/80 10pcs
04015630049943 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 8/110 10pcs
04015630049950 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 10/60 10pcs
04015630049967 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 10/80 10pcs
04015630049974 - Accu-Chek Ultraflex2023-07-25 Accu-Chek Ultraflex I 10/110 10pcs

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