FDA.reportPublic FDA data

iLet Connect Adapter

Primary DI
00850050080077
Brand
iLet Connect Adapter
Company
Beta Bionics, Inc.
Model
Insulin Only
Catalog number
BB3010
Device description
For use with the iLet Bionic Pancreas
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223846000iLet® ACE PumpBeta Bionics, Inc.2023-05-19QFG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050080091PrimaryGS10
00850050080145PrimaryGS10
00850050080077Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050080091008500500800918500500800910850050080091
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835742136
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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