FDA.reportPublic FDA data

Accu-Chek Link Assist

Primary DI
04015630048601
Brand
Accu-Chek Link Assist
Company
Roche Diabetes Care GmbH
Model
04530039001
Catalog number
04530039001
Device description
Accu-Chek Link Assist
Published
2016-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630048601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630048601040156300486014015630048601

GMDN Terms#

Term, Definition table
TermDefinition
Insulin infusion cannula introducerA non-sterile, hand-held, mechanical device intended to aid introduction of a cannula/needle subcutaneously into fatty tissue for use with an insulin infusion pump. It typically consists of a small housing that chambers the cannula and a triggered release mechanism for automated insertion of the cannula/needle into tissues. It is intended for use in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313212471
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04015630088928Accu-Chek Care10095946001100959460012024-11-07
04015630046713Accu-Chek Rapid-D04541103001045411030012016-08-23
04015630049929Accu-Chek Ultraflex04626583001046265830012016-08-25
04015630049936Accu-Chek Ultraflex04626591001046265910012016-08-25
04015630049943Accu-Chek Ultraflex04626605001046266050012016-08-25
04015630049950Accu-Chek Ultraflex04626613001046266130012016-08-25
04015630049967Accu-Chek Ultraflex04626621001046266210012016-08-25
04015630049974Accu-Chek Ultraflex04626648001046266480012016-08-25
04015630880119Accu-Chek Combo050272500012016-08-25
04015630882755Accu-Chek Spirit Cartridge04949935001049499350012016-08-26
04015630882908Accu-Chek Spirit Cartridge05206073001052060730012016-08-26
04015630883691Accu-Chek Combo05458382001054583820012016-08-25
04015630883806Accu-Chek Combo05458544001054585440012016-08-25
04015630888627Accu-Chek Ultraflex06593976001065939760012016-08-26
04015630888634Accu-Chek Ultraflex06593984001065939840012016-08-26
00075537474198Accu-Chek Compact Plus05599415160055994151602016-08-25
00075537927144Accu-Chek Compact Plus05919983160059199831602016-08-26
00064562213216Accu-Chek Softclix03146693119031466931192023-02-03
00064562213223Accu-Chek Softclix03146707119031467071192023-02-03
00064562213261Accu-Chek Safe-T-Pro03740838001037408380012023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncKZH2025-08-01
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.KZH2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12
05714472000004Needle Guide AssistantUnion Medico ApSKZH2025-05-05
B33935290030NeoMagicNeo Medical Inc.KZH2025-01-22
B33935290035NeoMagicNEO MEDICAL INC.KZH2025-01-22
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00817708022964AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00817708022988AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00643169705920Sil-serter™MEDTRONIC MINIMED, INC.KZH2022-09-17
00643169768086Minimed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
00763000573690MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
05713495000077Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
05713495000084Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
00763000381080Sil-serter™MEDTRONIC MINIMED, INC.KZH2021-04-22
00763000354817MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2020-06-14
05713495000015BETACONNECTPhillips-Medisize A/SKZH2019-10-07
00355513192019Onpro kitAMGEN INC.KZH2019-09-24
10355513192016Onpro kitAMGEN INC.KZH2019-09-24
00301697712901FlexPro® PenMate®NOVO NORDISK INC.KZH2019-08-08
00025294874007Inject-EaseAMBI, INC.KZH2018-12-17
57612799202398Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24