Bionic Circle App, iOS BB5001

GUDID 00850050080169

Bionic Circle App, iOS

Beta Bionics, Inc.

Ambulatory insulin infusion pump software, data-display

• Primary Device ID: 00850050080169
• NIH Device Record Key: 297948c6-e026-487a-ab18-f748d1c70583
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bionic Circle App, iOS
• Version Model Number: BOM000082
• Catalog Number: BB5001
• Company DUNS: 835742136
• Company Name: Beta Bionics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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	00850050080169 [Primary]

FDA Product Code

• PKU: Insulin Pump Secondary Display

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": 2024-11-21 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: 2024-11-21Bionic Circle App, iOS
• 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)