iLet Cartridge Kit BB2010

GUDID 00850050080053

For use with the iLet Bionic Pancreas

Beta Bionics, Inc.

Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00850050080053
• NIH Device Record Key: e2393545-ca52-4ace-bfeb-385b18db8bb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Cartridge Kit
• Version Model Number: Insulin Only
• Catalog Number: BB2010
• Company DUNS: 835742136
• Company Name: Beta Bionics, Inc.
• Device Count: 10
• 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
• 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	00850050080060 [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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by Beta Bionics, Inc.

• 00850050080121 - iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack: 2023-08-17 Pharmacy kit for use with the iLet Bionic Pancreas
• 00850050080022 - iLet Bionic Pancreas: 2023-06-22 iLet Bionic Pancreas (Pharmacy Starter Kit)
• 00850050080039 - iLet Bionic Pancreas: 2023-06-22 iLet Bionic Pancreas (Government Starter Kit)
• 00850050080046 - iLet Bionic Pancreas: 2023-06-22 iLet Bionic Pancreas (Commercial Starter Kit)
• 00850050080053 - iLet Cartridge Kit: 2023-06-22For use with the iLet Bionic Pancreas
• 00850050080053 - iLet Cartridge Kit: 2023-06-22 For use with the iLet Bionic Pancreas
• 00850050080077 - iLet Connect Adapter: 2023-06-22 For use with the iLet Bionic Pancreas
• 00850050080107 - iLet Insulin Infusion Kit – Inset™ (23", 6mm) 10-Pack: 2023-06-22 Pharmacy kit for use with the iLet Bionic Pancreas