FDA.reportPublic FDA data

Litetouch

Primary DI
00840216123465
Brand
Litetouch
Company
Asp Global, LLC
Model
20PS-BL
Device description
LITETOUCH LANCING DEVICE (DOLPHIN) - 1/EA, 1EA/BX, 100BX/IC, 4IC/MCS (400EA)
Published
2023-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840216123472PackageGS11In Commercial Distribution
10840216123462PackageGS1100In Commercial Distribution
20840216123469PackageGS1400In Commercial Distribution
00840216123465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216123472008402161234728402161234720840216123472
1084021612346210840216123462
2084021612346920840216123469
00840216123465008402161234658402161234650840216123465

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
080361159
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216128774ASP Global / PrimoCF120B2026-09-04
00840216103696ASP MEDICALMRT1322022-08-23
00840216127869Northside HospitalNSAMK-052026-07-23
00840216129290Quest DiagnosticsQD11X16KPAP2026-07-17
00840216129801LabCorpLC13X22BIO2026-07-17
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428167281TRUEplusTRIVIDIA HEALTH, INC.QRK2026-08-14
00050428167304TRUEplusTRIVIDIA HEALTH, INC.QRK2026-08-14
00050428167311TRUEplusTRIVIDIA HEALTH, INC.QRK2026-08-14
00050428167328TRUEplusTRIVIDIA HEALTH, INC.QRK2026-08-14
00050428167380TRUEplusTRIVIDIA HEALTH, INC.QRK2026-08-14
10080196395811MEDLINEMEDLINE INDUSTRIES, INC.QRK2026-07-22
06949517010017medisanaShandong Lianfa Medical Plastic Products CO.,LTDQRK2026-07-14
06949517010024medisanaShandong Lianfa Medical Plastic Products CO.,LTDQRK2026-07-14
00810011730755leraiseTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-06
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
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
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31