FDA.reportPublic FDA data

Bigfoot Unity

Primary DI
00850003506593
Brand
Bigfoot Unity
Company
Bigfoot Biomedical, Inc.
Model
FG-300993
Catalog number
FG-300993
Device description
Bigfoot Unity Support Kit
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
NBWSystem, Test, Blood Glucose, Over The Counter
QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
QOGInjection Data Capture Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery SystemsClinical Chemistry2
QOGInjection Data Capture DeviceGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202145000Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc.2021-05-07QLG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003506593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003506593008500035065938500035065930850003506593

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature46 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-523-3662customercare@bigfootbiomedical.com

Regulatory Flags#

DUNS number
079721177
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
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
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
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00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
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