iLet Inset Insulin Infusion Set (32”, 6mm) BB1011

GUDID 05705244026278

Insulin Infusion Sets for use with the iLet Bionic Pancreas

Beta Bionics, Inc.

Electric infusion pump administration set, single-use

• Primary Device ID: 05705244026278
• NIH Device Record Key: efa8b080-23b1-4185-8620-f1db9dc8392d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Inset Insulin Infusion Set (32”, 6mm)
• Version Model Number: Insulin Only
• Catalog Number: BB1011
• Company DUNS: 835742136
• Company Name: Beta Bionics, Inc.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080305 [Primary]
GS1	05705244026278 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032854

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-07
• Device Publish Date: 2025-06-27

On-Brand Devices [iLet Inset Insulin Infusion Set (32”, 6mm)]

• 00850050080268: Insulin Infusion Sets for use with the iLet Bionic Pancreas
• 05705244026278: Insulin Infusion Sets for use with the iLet Bionic Pancreas