FDA.reportPublic FDA data

Quality Choice Autolet

Primary DI
00635515959347
Brand
Quality Choice Autolet
Company
CHAIN DRUG MARKETING ASSOCIATION, INC.
Model
AT 0274QC
Device description
Quality Choice Autolet Lancing Device
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00761059276333PackageGS120In Commercial Distribution
00635515959347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059276333007610592763337610592763330761059276333
00635515959347006355159593476355159593470635515959347

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.

Regulatory Flags#

DUNS number
011920774
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00635515998537Quality Choice6355159985372021-08-09
00635515947443QUALITY CHOICE89-352QC-947442017-02-15
00635515958920QUALITY CHOICE89-362QC-958922017-02-15
00635515986701QUALITY CHOICE89-375QC-986702017-02-15
00635515992207QUALITY CHOICE89-355QC-992202017-02-15
00635515986794QUALITY CHOICE89-50KQC-986792017-02-15
00635515900486Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515956643Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00635515900493Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515970717Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00761059276333Quality Choice AutoletAT 0274QC2023-02-03
00635515959354Quality Choice UniletAT 0575QC2023-01-26
00635515959361Quality Choice UniletAT 0565QC2023-01-26
00635515994775Quality Choice UniletAT 0585QC2023-01-26
00635515966130Quality ChoiceQC-96613QC-966132022-06-16
10635515966137Quality ChoiceQC-96613QC-966132022-06-16
00635515958838Quality choice TamponsBQCGR202016-09-20
00635515958845Quality choice TamponsBQCGS182016-09-20
00635515958852Quality choice TamponsBQCGP182016-09-20
00635515958876Quality choice TamponsBQCAR402016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810011730700GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-11
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRL2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRL2026-05-06
00860015383952True IntegralTRUE INTEGRAL INCQRL2026-04-14
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
36945630142001STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
00850080988107AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRL2026-03-02
00810079240579Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRL2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRL2026-02-06
00682607541829On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
20682607541823On Call Stealth Lancing DeviceAcon Laboratories, Inc.QRL2026-02-03
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
50810011730644HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730656HuahongTianjin Huahong Technology Co., Ltd.QRL2025-12-24
00810011730663AllevyTianjin Huahong Technology Co., Ltd.QRL2025-12-24
06949517009462N/MShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-12-10
00850065253305LIVE TULA Lancing DeviceTULA HEALTH, INC.QRL2025-12-03
MHC1808002EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-11-10
00810079240456Teladoc Health, Inc.Teladoc Health, Inc.QRL2025-10-10
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
MHC1708001Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1730101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1732101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
06949517009028One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-09-14
MHC18080020EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-08-04
06949517008847One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRL2025-06-27