FDA.reportPublic FDA data

Quality Choice Unilet

Primary DI
00635515959361
Brand
Quality Choice Unilet
Company
CHAIN DRUG MARKETING ASSOCIATION, INC.
Model
AT 0565QC
Device description
Quality Choice Unilet Lancets Ultra Thin 28 Gauge for Sensitive Fingers
Published
2023-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00761059567332PackageGS1200In Commercial Distribution
00635515959361PrimaryGS10
00384700565008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059567332007610595673327610595673320761059567332
00635515959361006355159593616355159593610635515959361
00384700565008003847005650083847005650080384700565008

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge28Gauge

Regulatory Flags#

DUNS number
011920774
Device count
100
Lot or batch
true
Expiration 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
00635515959347Quality Choice AutoletAT 0274QC2023-02-03
00761059276333Quality Choice AutoletAT 0274QC2023-02-03
00635515959354Quality Choice UniletAT 0575QC2023-01-26
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
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