iLet Connect Adapter

Basic Information

• Brand Name: iLet Connect Adapter
• Primary DI: 00850050080091
• Version / Model: Insulin Only
• Catalog Number: BB3010
• Company Name: Beta Bionics, Inc.
• Labeler DUNS: 835742136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-06-14
• Public Version: 2
• Public Version Date: 2023-06-27
• Public Version Status: Update
• Public Device Record Key: b6d9a677-1c4b-45ac-b360-a3763d50ef54

Device Description

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
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	880.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60538	Luer/Luer linear connector, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850050080077	GS1
Primary	00850050080091	GS1

Customer Contacts

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