FDA.reportPublic FDA data

Bionic Circle App, iOS

Primary DI
00850050080169
Brand
Bionic Circle App, iOS
Company
Beta Bionics, Inc.
Model
BOM000082
Catalog number
BB5001
Device description
Bionic Circle App, iOS
Published
2024-11-13
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
PKUInsulin Pump Secondary Display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKUInsulin Pump Secondary DisplayClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050080169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050080169008500500801698500500801690850050080169

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump software, data-displayA software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be used on a non-medical computerized device (e.g., smartphone).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-745-3800xx@xx.xx

Regulatory Flags#

DUNS number
835742136
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050080374iLet Starter KitInsulin OnlyBB10182026-03-11
00850050080084"iLet Starter Kit - Inset 23"""Insulin OnlyBB10052024-11-13
00850050080237iLet Starter Kit - Contact DetachInsulin OnlyBB10082024-11-13
00850050080190iLet Bionic PancreasInsulin OnlyBB10032024-11-07
00850050080183 iLet Bionic PancreasInsulin OnlyBB10022024-11-06
00850050080206 iLet Bionic PancreasInsulin OnlyBB10042024-11-06
00850050080022 iLet Bionic PancreasInsulin OnlyBB10042023-06-14
00850050080039iLet Bionic PancreasInsulin OnlyBB10032023-06-14
00850050080046 iLet Bionic PancreasInsulin OnlyBB10022023-06-14
00850050080367iLet Insulin Infusion KitInsulin OnlyBB10172026-03-11
00850050080381iLet Insulin Infusion KitInsulin OnlyBB10192026-03-11
00850050080282iLet Inset Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10102025-06-27
00850050080299iLet Contact Detach Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10122025-06-27
00850050080305iLet Inset Insulin Infusion Set (32”, 6mm)Insulin OnlyBB10112025-06-27
05705244025226iLet Inset Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10102025-06-27
05705244025288iLet Contact Detach Insulin Infusion Set (23”, 6mm)Insulin OnlyBB10122025-06-27
05705244026278iLet Inset Insulin Infusion Set (32”, 6mm)Insulin OnlyBB10112025-06-27
00850050080145iLet Connect Adapter 15-Pack (BB3052)Insulin OnlyBB30522024-11-13
00850050080114"iLet Starter Kit - Inset 32"""Insulin OnlyBB10062024-11-13
00850050080138iLet Cartridge Kit 15-Pack (1.6mL/160 Units) Insulin OnlyBB20522024-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMEDTRONIC MINIMED, INC.PKU2025-09-26
00199150034130MiniMed Mobile AppMEDTRONIC MINIMED, INC.PKU2025-09-26
00850050080176Bionic Circle App, Android Beta Bionics, Inc.PKU2024-11-13
00763000968168MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-09-30
00763000968175MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-09-30
00763000943257MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-07-28
00763000943264MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-07-28
00763000791391CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2024-03-21
00763000910143MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2024-03-08
00763000910150MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-03-08
00763000867621MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2023-11-27
00763000867638MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-11-27
00763000521301MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-08-05
00763000827786MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-05-20
00763000827793MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-05-20
00763000827298CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2023-05-11
00763000827304CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2023-05-11
00763000432652CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2022-06-25
00763000432645CareLink ™ConnectMEDTRONIC MINIMED, INC.PKU2022-06-24
00763000480646CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2021-03-20
00763000480653CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2021-03-20
00763000480660MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2021-02-21
00763000480677MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2021-02-21
10385081120265Omnipod (Dash) Display App.Insulet CorporationPKU2021-02-20
10385081120272Omnipod (Dash) View APPInsulet CorporationPKU2021-02-20
00763000416676MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000416669MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000437794CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000437787CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2020-11-05
00763000168643Sugar.IQ™MEDTRONIC MINIMED, INC.PKU2018-12-27