FDA.reportPublic FDA data

Bigfoot Unity Report

Primary DI
00850003506517
Brand
Bigfoot Unity Report
Company
Bigfoot Biomedical, Inc.
Model
SW-300983
Catalog number
SW-300983
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
PHVContinuous Glucose Monitor Retrospective Data Analysis Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHVContinuous Glucose Monitor Retrospective Data Analysis SoftwareClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003506517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003506517008500035065178500035065170850003506517

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079721177
Device count
1
Premarket exempt
true
Lot or batch
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
B553202311OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202312OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202313OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202406OTC0Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-12-09
10385083000152Omnipod Discover Insulet CorporationPHV2025-12-04
B553202301OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202302OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202303OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202257OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-05-29
00763000984755CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2025-01-02
00763000984762CareLink™ ClinicMEDTRONIC MINIMED, INC.PHV2025-01-02
B553202057OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2024-12-27
00850018992435Sugarmate, iOS Mobile ApplicationSugarmate, LLCPHV2023-09-06
00850018992602Sugarmate, Mac Glance ApplicationSugarmate, LLCPHV2023-09-06
00850018992619Sugarmate, Web ApplicationSugarmate, LLCPHV2023-09-06
00850018992626Sugarmate, Alexa Skill ApplicationSugarmate, LLCPHV2023-09-06
00389152106113Tandem SourceTandem Diabetes Care, Inc.PHV2023-06-20
07290017735023endo.digitalDREAMED DIABETES LTDPHV2022-09-20
00817491023506Eversense DMSSENSEONICS, INCORPORATEDPHV2022-03-10
00817491023513Eversense DMS ProSENSEONICS, INCORPORATEDPHV2022-03-10
00357599826000LibreView GovernmentABBOTT DIABETES CARE INCPHV2021-07-15
00357599823009LibreViewABBOTT DIABETES CARE INCPHV2021-05-21
00763000424121CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2021-03-07
00763000424138CareLink™MEDTRONIC MINIMED, INC.PHV2021-03-07
00855093008033Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008040Cornerstones4Care® Powered by Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008026Glooko Web ApplicationGLOOKO, INC.PHV2021-02-16
00860000249515Onduo VERILY LIFE SCIENCES LLCPHV2020-08-25
00860000249522OnduoVERILY LIFE SCIENCES LLCPHV2020-08-25
00860000249539OnduoVERILY LIFE SCIENCES LLCPHV2020-08-25