FDA.reportPublic FDA data

iLet Connect Adapter 15-Pack (BB3052)

Primary DI
00850050080145
Brand
iLet Connect Adapter 15-Pack (BB3052)
Company
Beta Bionics, Inc.
Model
Insulin Only
Catalog number
BB3052
Device description
For use with the iLet Bionic Pancreas
Published
2024-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFGAlternate Controller Enabled Insulin Infusion Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFGAlternate Controller Enabled Insulin Infusion PumpClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050080145PrimaryGS10
00850050080077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050080145008500500801458500500801450850050080145
00850050080077008500500800778500500800770850050080077

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer linear connector, single-useA small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
835742136
Device count
15
Lot or batch
true
Expiration date on label
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
00850050080114"iLet Starter Kit - Inset 32"""Insulin OnlyBB10062024-11-13
00850050080138iLet Cartridge Kit 15-Pack (1.6mL/160 Units) Insulin OnlyBB20522024-11-13
00850050080169Bionic Circle App, iOSBOM000082BB50012024-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150077380MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-25
00199150021031MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-24
00763000848149MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00763000848156MiniMed FlexMEDTRONIC MINIMED, INC.QFG2026-05-21
00850050080367iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00850050080374iLet Starter KitBeta Bionics, Inc.QFG2026-03-11
00850050080381iLet Insulin Infusion KitBeta Bionics, Inc.QFG2026-03-11
00389152547244Tandem Mobi Mobile Application, AndroidTandem Diabetes Care, Inc.QFG2025-12-16
00389152858173Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152858777Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152859477Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-12-12
00389152852379Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152852973Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152853772Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854373Tandem Mobi TruSteel KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152854977Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152855578Tandem Mobi Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152856179Tandem Mobi Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152856971Tandem t:slim Autosoft 30 KitTandem Diabetes Care, Inc.QFG2025-12-10
00389152857572Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QFG2025-12-10
10385083000411Omnipod 5 PodInsulet CorporationQFG2025-12-04
20385083000425Omnipod 5 PodInsulet CorporationQFG2025-12-04
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.QFG2025-11-08
00389152690940Tandem Mobi Mobile Application, iOSTandem Diabetes Care, Inc.QFG2025-10-06
00389152706474Pharmacy Kit, Starter Pack, Tandem t:slim X2, Control IQ+Tandem Diabetes Care, Inc.QFG2025-05-23
00389152707679Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708379Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152708973Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QFG2025-05-23
00389152709574Tandem t:slim AutoSoft XC KitTandem Diabetes Care, Inc.QFG2025-05-23
00389152710174Tandem t:slimTruSteel KitTandem Diabetes Care, Inc.QFG2025-05-23