FDA.reportPublic FDA data

Bigfoot Unity

Primary DI
00850003506630
Brand
Bigfoot Unity
Company
Bigfoot Biomedical, Inc.
Model
FG-301187
Catalog number
FG-301187
Device description
Bigfoot Unity Pen Cap for Tresiba
Published
2023-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
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
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
00850003506630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003506630008500035066308500035066300850003506630

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial-fluid glucose monitoring system, electrochemicalAn assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 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
Serial number
true
Manufacturing 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
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
00850003506142Bigfoot Unity Diabetes Management SystemASM-10051ASM-100512021-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00357599805012FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599803018FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599804015FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
30357599805013FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
30357599803019FreeStyle Libre 2ABBOTT DIABETES CARE INCQLG2025-07-25
00357599840006Libre AppABBOTT DIABETES CARE INCQLG2024-12-17
00357599841003Libre AppABBOTT DIABETES CARE INCQLG2024-12-17
00850003506579Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-10-09
00850003506579Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-10-09
00850003506586Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-10-09
00850003506586Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-10-09
00850003506593Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-07-12
00850003506593Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-07-12
00850003506531Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506531Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506548Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506548Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506555Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506555Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506562Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506562Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506609Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506609Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506616Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506616Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506623Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506623Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506647Bigfoot UnityBigfoot Biomedical, Inc.QLG2023-04-03
00850003506647Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03
00850003506654Bigfoot UnityBigfoot Biomedical, Inc.QOG2023-04-03