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 00810111410038 LetsGetChecked Blood Sample Collection Kit (LIPP2) BO19S BO19S 2026-08-07 00810111410052 LetsGetChecked Blood Sample Collection Kit (HCV) BO36S BO36S 2026-08-07 00810111410182 LetsGetChecked Blood Sample Collection Kit (MHTP2) BO28S BO28S 2026-08-07 00810111410199 LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC) BS01S BS01S 2026-08-07 00810111410205 LetsGetChecked Blood Sample Collection Kit (MHTP) BO27S BO27S 2026-08-07 00810111410250 LetsGetChecked Blood Sample Collection Kit (ANMH2) BO11S BO11S 2026-08-07 00810111410366 LetsGetChecked Blood Sample Collection Kit (TRFNUS+) BO06S BO06S 2026-08-07 00810111410533 LetsGetChecked Blood and Urine Sample Collection Kit (ST04) BU09S BU09S 2026-08-07 00810111410540 LetsGetChecked Blood Sample Collection Kit (GLCS) BO47S BO47S 2026-08-07 00810111410557 LetsGetChecked Blood Sample Collection Kit (LEAD) BO39S BO39S 2026-08-07 00810111410588 LetsGetChecked Blood Sample Collection Kit (HPSP) BO17S BO17S 2026-08-07 00810111410601 LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED) BU08S BU08S 2026-08-07 00810111410649 LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV) BO48S BO48S 2026-08-07 00810111410663 LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2) BU11S BU11S 2026-08-07 00810111410670 LetsGetChecked Vaginal HPV Sample Collection Kit (HPVT & HPVT2) VS01S VS01S 2026-08-07 00810111410694 LetsGetChecked Blood Sample Collection Kit (EWB1) BO50S BO50S 2026-08-07 00810111410700 LetsGetChecked Blood Sample Collection Kit (EDB1) BO51S BO51S 2026-08-07 00810111410724 LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C) BU06S BU06S 2026-08-07 00810111410793 LetsGetChecked Blood Sample Collection Kit (KDRN) BO14S BO14S 2026-08-07 00810111410809 LetsGetChecked Blood and Urine Sample Collection Kit (ST05) BU04S BU04S 2026-08-07
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