FDA.reportPublic FDA data

Accu-Chek Softclix

Primary DI
10064562213220
Brand
Accu-Chek Softclix
Company
Roche Diabetes Care GmbH
Model
03146707119
Catalog number
03146707119
Device description
Accu-Chek Softclix Lancet 100 (CND, US)
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10064562213220PackageGS112In Commercial Distribution
00064562213223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1006456221322010064562213220
00064562213223000645622132230645622132230064562213223

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, reusableA hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313212471
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04015630088928Accu-Chek Care10095946001100959460012024-11-07
04015630046713Accu-Chek Rapid-D04541103001045411030012016-08-23
04015630048601Accu-Chek Link Assist04530039001045300390012016-08-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00860015786838True IntegralTRUE INTEGRAL INCQRK2026-05-20
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRK2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-06
00860015383969True IntegralTRUE INTEGRAL INCQRK2026-04-14
00682607541072On Call Lancets (33G)Acon Laboratories, Inc.QRK2026-03-30
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142014STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142021STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142038STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142045STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142069STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
00197344174433CARINGMEDLINE INDUSTRIES, INC.QRK2026-03-03
00850080988107AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00682607541058On Call Lancets 30GAcon Laboratories, Inc.QRK2026-02-19
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00810079240609Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRK2026-02-06
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRK2025-12-24
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17