iLet Inset Insulin Infusion Set (23”, 6mm)

Basic Information

• Brand Name: iLet Inset Insulin Infusion Set (23”, 6mm)
• Primary DI: 00850050080282
• Version / Model: Insulin Only
• Catalog Number: BB1010
• Company Name: Beta Bionics, Inc.
• Labeler DUNS: 835742136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-06-27
• Public Version: 1
• Public Version Date: 2025-07-07
• Public Version Status: New
• Public Device Record Key: 96122a51-0072-44b7-8eea-1cf9f2bb2921

Device Description

Insulin Infusion Sets for use with the iLet Bionic Pancreas

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35833	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05705244025226	GS1
Primary	00850050080282	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032854	000