FDA.reportPublic FDA data

D-Care

Primary DI
00370914001005
Brand
D-Care
Company
HUDSON SCIENTIFIC, LLC
Model
50001A
Device description
Glucose Monitoring Kit includes Glucose Meter, Test Strip, Lancing Device, Lancets and 7 Information Inserts.
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
10370914001002PackageGS110In Commercial Distribution
20370914001009PackageGS140In Commercial Distribution
00370914001005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037091400100210370914001002
2037091400100920370914001009
00370914001005003709140010053709140010050370914001005

GMDN Terms#

Term, Definition table
TermDefinition
Home-use blood glucose spot-check systemAn electrically-powered, portable device assembly intended to spot-check (user-initiated) measure and display blood glucose concentration in a patient with diabetes mellitus; it is not intended for continuous measurements (i.e., not a monitor). 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 measurements, typically on a finger, without blood draw; it also includes test strips, lancets, control solutions, and 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

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
00370914003054D-Care50003A2017-07-24
00370914006017D-Care50002A2017-07-24
20370914012005CycloTens Starter Pak50053A2017-07-24
00370914013015CycloTens Refill Pak50054A2017-07-24
20370914001009D-Care50001A2017-07-24
20370914013019CycloTens Refill Pak50054A2017-07-24

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Primary DI, Brand, Company table
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05700699461131SC90Radiometer Medical ApSCGA2026-07-09
05700699461605SC90Radiometer Medical ApSCGA2026-07-09
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00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
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06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
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