FDA.reportPublic FDA data

CareTouch

Primary DI
00810128750141
Brand
CareTouch
Company
Tianjin Empecs Medical Device Co.,Ltd
Model
CTMK w/cs
Device description
Mixed Case: CareTouch Blood Glucose Monitoring System + CareTouch Blood Glucose Test Strip + CareTouch Glucose Control Solution
Published
2023-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111456000MEDISIGN BLOOD GLUCOSE MONITORING SYSTEMTianjin Empecs Medical Device Co., Ltd.2012-02-28NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810128750141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810128750141008101287501418101287501410810128750141

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-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 for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature39.2 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
866-890-8500info@caretouchusa.com

Regulatory Flags#

DUNS number
529128638
Device count
1
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810128750462Mac0.14mm-13mm2026-04-22
00810128752244MedisignMM1200 Strip2026-04-22
00810128752343MedisignGH81 Test Strip2026-04-22
00810128750028CareTouchCT1002023-01-13
00810128750059CareTouchCT2-32023-01-13
00810128750097CareTouchCT502023-01-13
00810128750127CareTouchCTMK2023-01-13
00810128750134CareTouchCTMK502023-01-13
00810128750158CareTouchCTMK1502023-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08718734960584Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960607Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960621Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08718734960645Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
10096295139553TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-04-10
10021292014299TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014305TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014312TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014329TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18