FDA.reportPublic FDA data

Bigfoot Test Strips Blood Glucose Test Strips

Primary DI
30850003506006
Brand
Bigfoot Test Strips Blood Glucose Test Strips
Company
Bigfoot Biomedical, Inc.
Model
FG-300295
Catalog number
FG-300295
Device description
Bigfoot Test Strips Blood Glucose Test Strips 50CT
Published
2021-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850003506006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085000350600630850003506006

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

Contacts#

Phone, Email table
PhoneEmail
551-244-3668customercare@bigfootbiomedical.com

Regulatory Flags#

DUNS number
079721177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003506579Bigfoot UnityFG-300998FG-3009982023-10-09
00850003506586Bigfoot UnityFG-300999FG-3009992023-10-09
00850003506531Bigfoot UnityFG-300994FG-3009942023-04-03
00850003506548Bigfoot UnityFG-300995FG-3009952023-04-03
00850003506555Bigfoot UnityFG-300996FG-3009962023-04-03
00850003506562Bigfoot UnityFG-300997FG-3009972023-04-03
00850003506609Bigfoot UnityFG-301184FG-3011842023-04-03
00850003506616Bigfoot UnityFG-301185FG-3011852023-04-03
00850003506623Bigfoot UnityFG-301186FG-3011862023-04-03
00850003506630Bigfoot UnityFG-301187FG-3011872023-04-03
00850003506647Bigfoot UnityFG-301188FG-3011882023-04-03
00850003506654Bigfoot UnityFG-301190FG-3011902023-04-03
00850003506661Bigfoot UnityFG-301189FG-3011892023-04-03
00850003506678Bigfoot UnityFG-301191FG-3011912023-04-03
00850003506685Bigfoot UnityFG-301192FG-3011922023-04-03
00850003506524Bigfoot UnityFG-300992FG-3009922023-03-30
00850003506074Bigfoot Unity Diabetes Management SystemSW-300842SW-3008422021-06-29
00850003506111Bigfoot Unity Diabetes Management SystemASM-10027ASM-100272021-06-29
00850003506128Bigfoot Unity Diabetes Management SystemASM-10043ASM-100432021-06-29
00850003506135Bigfoot Unity Diabetes Management SystemASM-10050ASM-100502021-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
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30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
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
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
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