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
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242680000LetsGetChecked ImpressPrivapath Diagnostics Ltd (Dba Letsgetchecked)2025-01-13FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111410847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111410847008101114108478101114108470810111410847

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA 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 DIBrandModelCatalogPublished
00810111410038LetsGetChecked Blood Sample Collection Kit (LIPP2)BO19SBO19S2026-08-07
00810111410052LetsGetChecked Blood Sample Collection Kit (HCV)BO36SBO36S2026-08-07
00810111410182LetsGetChecked Blood Sample Collection Kit (MHTP2)BO28SBO28S2026-08-07
00810111410199LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC)BS01SBS01S2026-08-07
00810111410205LetsGetChecked Blood Sample Collection Kit (MHTP)BO27SBO27S2026-08-07
00810111410250LetsGetChecked Blood Sample Collection Kit (ANMH2)BO11SBO11S2026-08-07
00810111410366LetsGetChecked Blood Sample Collection Kit (TRFNUS+)BO06SBO06S2026-08-07
00810111410533LetsGetChecked Blood and Urine Sample Collection Kit (ST04)BU09SBU09S2026-08-07
00810111410540LetsGetChecked Blood Sample Collection Kit (GLCS)BO47SBO47S2026-08-07
00810111410557LetsGetChecked Blood Sample Collection Kit (LEAD)BO39SBO39S2026-08-07
00810111410588LetsGetChecked Blood Sample Collection Kit (HPSP)BO17SBO17S2026-08-07
00810111410601LetsGetChecked Blood and Urine Sample Collection Kit (CKDRN2 & GLCSKED)BU08SBU08S2026-08-07
00810111410649LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV)BO48SBO48S2026-08-07
00810111410663LetsGetChecked Blood and Urine Sample Collection Kit (KDB1 & KDB2)BU11SBU11S2026-08-07
00810111410670LetsGetChecked Vaginal HPV Sample Collection Kit (HPVT & HPVT2)VS01SVS01S2026-08-07
00810111410694LetsGetChecked Blood Sample Collection Kit (EWB1)BO50SBO50S2026-08-07
00810111410700LetsGetChecked Blood Sample Collection Kit (EDB1)BO51SBO51S2026-08-07
00810111410724LetsGetChecked Blood and Urine Sample Collection Kit (CM08B & CM08C)BU06SBU06S2026-08-07
00810111410793LetsGetChecked Blood Sample Collection Kit (KDRN)BO14SBO14S2026-08-07
00810111410809LetsGetChecked Blood and Urine Sample Collection Kit (ST05)BU04SBU04S2026-08-07

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