FDA.reportPublic FDA data

XPER Technology Multi-Functional Monitoring System Procheck Smart

Primary DI
04710469879548
Brand
XPER Technology Multi-Functional Monitoring System Procheck Smart
Company
TAIDOC TECHNOLOGY CORPORATION
Model
TD-4140
Device description
Lancet Strip stripLancing device
Published
2025-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol
JINNitroprusside, Ketones (Urinary, Non-Quant.)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710469879548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710469879548047104698795484710469879548

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte monitoring system IVD, home-useA collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care.

Regulatory Flags#

DUNS number
658530993
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719893233827XPER Technology Procheck Witty Procheck Smart Blood Glucose Test StripsTD-43352025-10-30
04719893237139TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)TD-50522025-11-25
04719893237153TD-5052 AKTIVSAFE LANCET (Sterile) (26G) (100PCS/BOX)TD-50522025-11-25
04719893237177TD-5052 AKTIVSAFE LANCET (Sterile) (30G) (100PCS/BOX)TD-50522025-11-25
04710469874642Uright TD-1242 Forehead ThermometerTD-1242A2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTD-41432025-10-30
04710636645921MbH (Mobile Health) TD-3140 Blood Pressure TD-31402025-10-30
04719893233834XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test StripsTD-46422025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTD-46312025-10-30
04710469874635CLEVER TD-1242 Forehead ThermometerTD-1242B2025-10-29
04713106028187URIGHT Hemoglobin A1c AnalyzerTD-46112025-03-26
04710469873409Forehead Thermometer TD-1261TD-12612020-02-20
04710636640162TD-THIN Sterile Lancets (100pcs/box)TD-50842023-08-31
04717095034143MbH Fingertip Pulse OximeterTD-82552020-05-15
04710469873973CLEVER TD-1242 FOREHEAD THERMOMETERTD-12422021-10-28
04710469874581DIRECT SUPPLY Attendant ACTT-1 Tympanic ThermometerTD-11072020-06-01
04710469874598DIRECT SUPPLY Attendant Tympanic Thermometer Probe Cover (300pce/Box)TD-11072020-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIN2022-04-13
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24