FDA.reportPublic FDA data

FondCircle

Primary DI
00850070979214
Brand
FondCircle
Company
FondCircle Inc.
Model
M1-SL100
Device description
Blood Glucose Test Strips Kit
Published
2025-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter
QRLMultiple Use Blood Lancet For Single Patient Use Only

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
QRLMultiple Use Blood Lancet For Single Patient Use OnlyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191657000Bioland Blood Glucose Monitoring SystemBioland Technology, Ltd.2020-03-20NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070979214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070979214008500709792148500709792140850070979214

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060715854
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850070979122FondCircleFBP-U12025-01-14
00850070979207FondCircleM1-SL502025-03-12
00850070979184FondCircleM1-L502025-03-10
00850070979160FondCircleFTM-B12025-01-14
00850070979283FondCircleIK2025-04-06
00850070979290FondCircleM1-SL1002025-04-06
00850070979306FondCircleM1-SL502025-04-06
00850070979313FondCircleFBG-M12025-04-06
00850070979252FondCircleM1-S502025-03-18
00850070979221FondCircleM1-S252025-03-14
00850070979238FondCircleM12025-03-14
00850070979191FondCircleM1-S502025-02-26
00850070979047FondCircleFBG-M22025-01-14
00850070979054FondCircleFBG-M12025-01-14
00850070979061FondCircleFBF-F42025-01-14
00850070979078FondCircleFBF-F32025-01-14
00850070979085FondCircleFBF-F22025-01-14
00850070979092FondCircleFBF-F12025-01-14
00850070979108FondCircleFBF-W12025-01-14
00850070979115FondCircleFBP-W12025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194631000024Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000031Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000048Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000062Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
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
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
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
16945630136167TRANSTEKSterilance Medical (Suzhou) Inc.QRL2025-04-22
16945630132527STERiLANCE LDE4 Lancing DeviceSterilance Medical (Suzhou) Inc.QRL2024-10-23
16945630132534STERiLANCE Soft Disposable Blood LancetSterilance Medical (Suzhou) Inc.QRL2024-10-23
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
20612479265664McKessonMCKESSON MEDICAL-SURGICAL INC.QRL2024-01-30
20612479265695McKessonMCKESSON MEDICAL-SURGICAL INC.QRL2024-01-30
16945630123488SteriLance OneStepSterilance Medical (Suzhou) Inc.QRL2024-01-15
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10810011730257Care TouchTianjin Huahong Technology Co., Ltd.QRL2023-04-28
10810011730264Care TouchTianjin Huahong Technology Co., Ltd.QRL2023-04-28
10810011730271Care TouchTianjin Huahong Technology Co., Ltd.QRL2023-04-28
10810011730288Care TouchTianjin Huahong Technology Co., Ltd.QRL2023-04-28
10810011730295Care TouchTianjin Huahong Technology Co., Ltd.QRL2023-04-28