FDA.reportPublic FDA data

STAT Medical Devices

Primary DI
00709334992004
Brand
STAT Medical Devices
Company
Stat Medical Devices, Inc.
Model
TRIO Lancing Device
Catalog number
SM-TLD-L02
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
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230310000STAT Medical Device Lancing SystemStat Medical Devices2023-09-08QRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00709334992004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00709334992004007093349920047093349920040709334992004

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
967687286
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709334761884STAT Medical DevicesQwik-Lance Safety LancetRQN-1002024-01-04
40709334761882STAT Medical DevicesQwik-Lance Safety LancetRQN-1002024-01-04
00709334581215STAT Medical DevicesComfort Thins Twist-Off LancetBTM-1002023-11-28
00709334883883STAT Medical DevicesQwik-Lance Safety LancetRQL-1002023-11-28
50709334581210STAT Medical DevicesComfort Thins Twist-Off LancetBTM-1002023-11-28
30709334883884STAT Medical DevicesQwik-Lance Safety LancetRQL-1002023-11-28
00709334980001STAT Medical DevicesLITE Lancing DeviceSM-QLL-L022023-11-28

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
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
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
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
MHC1808002EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-11-10
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRL2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
MHC1708001Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1730101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
MHC1732101Members MarkMHC MEDICAL PRODUCTS, LLCQRL2025-09-16
16945630139311STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
16945630139328STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-09-10
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20