FDA.reportPublic FDA data

D-Care

Primary DI
00370914006017
Brand
D-Care
Company
HUDSON SCIENTIFIC, LLC
Model
50002A
Device description
DM2- kit contains one 60ct. bottle of Metformin 500mg and one 50ct. bottle Test Strips
Published
2017-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K132086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132086000ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEMACON Laboratories, Inc.2013-12-19NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10370914006014PackageGS110In Commercial Distribution
20370914006011PackageGS1120Not in Commercial Distribution
00370914006017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037091400601410370914006014
2037091400601120370914006011
00370914006017003709140060173709140060170370914006017

GMDN Terms#

Term, Definition table
TermDefinition
Home-use blood glucose spot-check analysis systemA portable, mains electricity (AC-powered) device assembly, with a rechargeable battery, intended to electronically measure and display blood glucose concentration for intermittent spot-check measuring. It includes a quantitative glucose meter that uses a blood specimen for the personal calibration of a noninvasive qualitative measurement device (e.g., near-infrared spectroscopy) which performs the spot-check/trending measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and other associated materials. It is designed to be used by a layperson in the home, and some types may in addition be used at the point-of-care.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5172124047angela.powell@hudsci.com

Regulatory Flags#

DUNS number
080339637
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370914012001CycloTens Starter Pak50053A2017-07-24
00370914030012Alzair Allergy Blocker501312017-09-19
00370914001005D-Care50001A2017-07-24
00370914003054D-Care50003A2017-07-24
20370914012005CycloTens Starter Pak50053A2017-07-24
00370914013015CycloTens Refill Pak50054A2017-07-24
20370914001009D-Care50001A2017-07-24
20370914013019CycloTens Refill Pak50054A2017-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
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
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
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