iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit) BB4210

GUDID 00850050080213

Pharmacy kit for use with the iLet Bionic Pancreas

Beta Bionics, Inc.

Electric infusion pump administration set, single-use

• Primary Device ID: 00850050080213
• NIH Device Record Key: bcfe9bca-c3cf-4364-8162-ff2f60a97ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit)
• Version Model Number: Insulin Only
• Catalog Number: BB4210
• Company DUNS: 835742136
• Company Name: Beta Bionics, Inc.
• Device Count: 1
• 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
• Phone: 855-745-3800
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080213 [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.

• 05705244025226 - iLet Inset Insulin Infusion Set (23”, 6mm): 2025-07-07 Insulin Infusion Sets for use with the iLet Bionic Pancreas
• 05705244025288 - iLet Contact Detach Insulin Infusion Set (23”, 6mm): 2025-07-07 Insulin Infusion Sets for use with the iLet Bionic Pancreas
• 05705244026278 - iLet Inset Insulin Infusion Set (32”, 6mm): 2025-07-07 Insulin Infusion Sets for use with the iLet Bionic Pancreas
• 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