Home GUDID 00810111410847 LetsGetChecked ImPress
Primary DI 00810111410847
Brand LetsGetChecked ImPress
Company PRIVAPATH DIAGNOSTICS LIMITED
Model IMPRS
Device description The LetsGetChecked lmPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressedagainst the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.
Published 2026-04-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810111410847 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810111410847 00810111410847 810111410847 0810111410847
GMDN Terms# Term, Definition table Term Definition Manual blood lancing device, single-use A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded 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 single-use device.
Regulatory Flags# DUNS number 985578451 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810111410748 Simple 2 test (Simple 2 Urine Home Collection Kit (Penile)) UO01S 2025-07-07 00850024881860 LetsGetChecked Blood Sample Collection Kit (BIOM2) BO43S 2026-05-06 00810111410731 Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal) VS01S 2026-04-15 00810111410045 LetsGetChecked Blood Sample Collection Kit (LIPP2) BO19S BO19S 2025-07-07 00810111410281 LetsGetChecked Blood Sample Collection Kit (PRGS) BO10S BO10S 2025-07-07 00810111410335 LetsGetChecked Blood Sample Collection Kit (TSTS) BO08S 2025-07-07 00850024881846 LetsGetChecked Urine Sample Collection Kit (UACR/UACRL) UO03S 2025-07-07 00850024881327 LetsGetChecked Urine Sample Collection Kit (SM02) UO305, UO01S UO305, UO01S 2022-03-30 00810111410212 LetsGetChecked Blood Sample Collection Kit (MIC9) BO35S BO35S 2023-07-28 00850024881976 LetsGetChecked Blood Sample Collection Kit (GLCS) B026S B026S 2023-01-16 00810111410014 LetsGetChecked Blood Sample Collection Kit (FMHM) BO20S BO20S 2022-09-30 00810111410175 LetsGetChecked Blood Sample Collection Kit (MHTB) BO12S BO12S 2022-09-30 00810111410342 LetsGetChecked Blood Sample Collection Kit (TRFN) BO07S BO07S 2022-09-30 00810111410090 LetsGetChecked Blood Sample Collection Kit (HPTT) BO18S BO18S 2022-10-03 00810111410106 LetsGetChecked Blood Sample Collection Kit (HPSP) BO17S BO17S 2022-07-01 00850024881310 LetsGetChecked Blood Sample Collection Kit (MHTB) BO112, BO903, BO12S BO112, BO903, BO12S 2022-04-05 00850024881471 LetsGetChecked Blood Sample Collection Kit (TRFN) BO120, BO190 BO120, BO190 2022-04-05 00850024881020 LetsGetChecked Blood Sample Collection Kit (FOLT) BO125 BO125 2022-04-01 00850024881594 LetsGetChecked Blood Sample Collection Kit (TRFNUS+) BO06S BO06S 2022-04-01 00860002028095 LetsGetChecked Coronavirus (COVID-19) Home Sample Collection Test NO14S, NO15S, NO05S 2023-01-25
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