iLet Starter Kit - Contact Detach BB1008

GUDID 00850050080237

iLet Bionic Pancreas Starter Kit with consumables (Pharmacy Starter Kit)

Beta Bionics, Inc.

Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 00850050080237
• NIH Device Record Key: 0d1e59af-08dc-40ac-a0b8-b8e8a1e3f24a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Starter Kit - Contact Detach
• Version Model Number: Insulin Only
• Catalog Number: BB1008
• Company DUNS: 835742136
• Company Name: Beta Bionics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080237 [Primary]

FDA Product Code

• QJI: Interoperable Automated Glycemic Controller

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by Beta Bionics, Inc.

• 05705244025226 - iLet Inset Insulin Infusion Set (23”, 6mm): 2025-07-07 Insulin Infusion Sets for use with the iLet Bionic Pancreas
• 05705244025288 - iLet Contact Detach Insulin Infusion Set (23”, 6mm): 2025-07-07 Insulin Infusion Sets for use with the iLet Bionic Pancreas
• 05705244026278 - iLet Inset Insulin Infusion Set (32”, 6mm): 2025-07-07 Insulin Infusion Sets for use with the iLet Bionic Pancreas
• 00850050080084 - iLet Starter Kit - Inset 23": 2024-11-21 iLet Bionic Pancreas Starter Kit with consumables (Pharmacy Starter Kit)
• 00850050080114 - iLet Starter Kit - Inset 32": 2024-11-21 iLet Bionic Pancreas Starter Kit with consumables (Pharmacy Starter Kit)
• 00850050080138 - iLet Cartridge Kit 15-Pack (1.6mL/160 Units): 2024-11-21 For use with the iLet Bionic Pancreas
• 00850050080169 - Bionic Circle App, iOS: 2024-11-21 Bionic Circle App, iOS
• 00850050080176 - Bionic Circle App, Android: 2024-11-21 Bionic Circle App, Android