Home GUDID 05705244025288
iLet Contact Detach Insulin Infusion Set (23”, 6mm)
Primary DI 05705244025288
Brand iLet Contact Detach Insulin Infusion Set (23”, 6mm)
Company Beta Bionics, Inc.
Model Insulin Only
Catalog number BB1012
Device description Insulin Infusion Sets for use with the iLet Bionic Pancreas
Published 2025-06-27
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
Product Codes# Code, Name table Code Name FPA Set, Administration, Intravascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FPA Set, Administration, Intravascular General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850050080299 Primary GS1 0 05705244025288 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850050080299 00850050080299 850050080299 0850050080299 05705244025288 05705244025288 5705244025288
GMDN Terms# Term, Definition table Term Definition Electric infusion pump administration set, single-use A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.
Regulatory Flags# DUNS number 835742136 Device count 2 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 DI Brand Model Catalog Published 00850050080374 iLet Starter Kit Insulin Only BB1018 2026-03-11 00850050080084 "iLet Starter Kit - Inset 23""" Insulin Only BB1005 2024-11-13 00850050080237 iLet Starter Kit - Contact Detach Insulin Only BB1008 2024-11-13 00850050080190 iLet Bionic Pancreas Insulin Only BB1003 2024-11-07 00850050080183 iLet Bionic Pancreas Insulin Only BB1002 2024-11-06 00850050080206 iLet Bionic Pancreas Insulin Only BB1004 2024-11-06 00850050080022 iLet Bionic Pancreas Insulin Only BB1004 2023-06-14 00850050080039 iLet Bionic Pancreas Insulin Only BB1003 2023-06-14 00850050080046 iLet Bionic Pancreas Insulin Only BB1002 2023-06-14 00850050080367 iLet Insulin Infusion Kit Insulin Only BB1017 2026-03-11 00850050080381 iLet Insulin Infusion Kit Insulin Only BB1019 2026-03-11 00850050080282 iLet Inset Insulin Infusion Set (23”, 6mm) Insulin Only BB1010 2025-06-27 00850050080299 iLet Contact Detach Insulin Infusion Set (23”, 6mm) Insulin Only BB1012 2025-06-27 00850050080305 iLet Inset Insulin Infusion Set (32”, 6mm) Insulin Only BB1011 2025-06-27 05705244025226 iLet Inset Insulin Infusion Set (23”, 6mm) Insulin Only BB1010 2025-06-27 05705244026278 iLet Inset Insulin Infusion Set (32”, 6mm) Insulin Only BB1011 2025-06-27 00850050080145 iLet Connect Adapter 15-Pack (BB3052) Insulin Only BB3052 2024-11-13 00850050080114 "iLet Starter Kit - Inset 32""" Insulin Only BB1006 2024-11-13 00850050080138 iLet Cartridge Kit 15-Pack (1.6mL/160 Units) Insulin Only BB2052 2024-11-13 00850050080169 Bionic Circle App, iOS BOM000082 BB5001 2024-11-13
Other Devices Sharing Product Codes#