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
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• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
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• Phone: 855-745-3800
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• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
• Email: xx@xx.xx
• Phone: 855-745-3800
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• Phone: 855-745-3800
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• Phone: 855-745-3800
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• Phone: 855-745-3800
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• Phone: 855-745-3800
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• 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
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• Phone: 855-745-3800
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• Phone: 855-745-3800
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• Phone: 855-745-3800
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• Phone: 855-745-3800
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00850050080077 [Unit of Use]
GS1	00850050080091 [Primary]
GS1	00850050080145 [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.

• 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