FDA.reportPublic FDA data

CareSens S

Primary DI
00385540109742
Brand
CareSens S
Company
AGAMATRIX, INC.
Model
8000-10974
Device description
CareSens S Test Strip 50ct Vial
Published
2025-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180866000CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc.2018-08-31NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385540109742PackageGS11In Commercial Distribution
00385540109766PackageGS12In Commercial Distribution
20385540109746PackageGS124In Commercial Distribution
20385540109760PackageGS112In Commercial Distribution
30385540109743PackageGS120In Commercial Distribution
30385540109767PackageGS18In Commercial Distribution
10385540109749PrimaryGS10
08038554010970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385540109742003855401097423855401097420385540109742
00385540109766003855401097663855401097660385540109766
2038554010974620385540109746
2038554010976020385540109760
3038554010974330385540109743
3038554010976730385540109767
1038554010974910385540109749
08038554010970080385540109708038554010970

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
156756129
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10385540109732CareSens S Fit BT8000-109732025-11-30
10385540109749CareSens S8000-109742025-08-04
00385540109728CareSens S Fit8000-109722025-08-04
00385540109759CareSens S8000-109752025-08-04
00385540132504AgaMatrix Lancing Device8300-013252023-09-18
00385541062206AgaMatrix Lancing Device8300-106222023-09-18
10385541001509AgaMatrix8000-033902016-11-04
10385541003305AgaMatrix8000-105192016-11-04
10385541003503AgaMatrix8000-105202016-11-04
10385542013013AgaMatrix8000-020132016-11-04
10385543334018AgaMatrix8000-033342016-11-04
10385544034016AgaMatrix8000-040342016-11-04
00385541000802AgaMatrix8000-040882016-11-04
00385541001908AgaMatrix8000-104742016-07-11
00385541002103AgaMatrix8000-104732016-07-11
00385541002608AgaMatrix8000-104712016-07-11
00385541833011AgaMatrix8000-01833N/A2023-01-06
00385541971010AgaMatrix8000-01971N/A2023-01-06
00385542649017AgaMatrix8000-026492016-11-04
00385543764023AgaMatrix8000-037642016-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
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
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19