iLet Starter Kit - Inset 23" BB1005

GUDID 00850050080084

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

Beta Bionics, Inc.

Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 00850050080084
• NIH Device Record Key: d1365103-15c8-4efe-b958-76c2e9539cc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Starter Kit - Inset 23"
• Version Model Number: Insulin Only
• Catalog Number: BB1005
• Company DUNS: 835742136
• Company Name: Beta Bionics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080084 [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.

• 00850050080084 - iLet Starter Kit - Inset 23": 2024-11-21iLet Bionic Pancreas Starter Kit with consumables (Pharmacy Starter Kit)
• 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
• 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)