iLet Cartridge Kit 15-Pack (1.6mL/160 Units) BB2052

GUDID 00850050080138

For use with the iLet Bionic Pancreas

Beta Bionics, Inc.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00850050080138
• NIH Device Record Key: 806c5419-6740-4d66-ab16-022d07bdf16c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Cartridge Kit 15-Pack (1.6mL/160 Units)
• Version Model Number: Insulin Only
• Catalog Number: BB2052
• Company DUNS: 835742136
• Company Name: Beta Bionics, Inc.
• Device Count: 15
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080053 [Unit of Use]
GS1	00850050080138 [Primary]

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

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: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by Beta Bionics, Inc.

• 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): 2024-11-21For use with the iLet Bionic Pancreas
• 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
• 00850050080213 - iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit): 2024-11-21 Pharmacy kit for use with the iLet Bionic Pancreas
• 00850050080220 - iLet Insulin Infusion Kit – Contact Detach (23”, 6mm) 15-Pack (Pharmacy Kit): 2024-11-21 Pharmacy kit for use with the iLet Bionic Pancreas
• 00850050080237 - iLet Starter Kit - Contact Detach: 2024-11-21 iLet Bionic Pancreas Starter Kit with consumables (Pharmacy Starter Kit)