iLet Connect Adapter BB3010

GUDID 00850050080077

For use with the iLet Bionic Pancreas

Beta Bionics, Inc.

Luer/Luer linear connector, single-use

• Primary Device ID: 00850050080077
• NIH Device Record Key: b6d9a677-1c4b-45ac-b360-a3763d50ef54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Connect Adapter
• Version Model Number: Insulin Only
• Catalog Number: BB3010
• 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: 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
• 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
• Phone: 855-745-3800
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080077 [Unit of Use]
GS1	00850050080091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223846

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.

• 00850050080190 - iLet Bionic Pancreas: 2024-11-15 iLet Bionic Pancreas (Government Starter Kit)
• 00850050080183 - iLet Bionic Pancreas: 2024-11-14 iLet Bionic Pancreas (Commercial Starter Kit)
• 00850050080206 - iLet Bionic Pancreas: 2024-11-14 iLet Bionic Pancreas (Pharmacy Starter Kit)
• 00850050080008 - iLet Insulin Infusion Kit – Inset™ (32") 10-Pack: 2024-08-06 Pharmacy kit for use with the iLet Bionic Pancreas
• 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)