iLet Bionic Pancreas

Basic Information

• Brand Name: iLet Bionic Pancreas
• Primary DI: 00850050080022
• Version / Model: Insulin Only
• Catalog Number: BB1004
• Company Name: Beta Bionics, Inc.
• Labeler DUNS: 835742136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: b9951b12-c1a5-434a-a565-e33c4451f61e

Device Description

iLet Bionic Pancreas (Pharmacy Starter Kit)

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	862.1356	2
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	880.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60770	Ambulatory insulin infusion pump/interstitial glucose monitoring system	An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850050080022	GS1

Customer Contacts

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