iLet Bionic Pancreas BB1004

GUDID 00850050080022

iLet Bionic Pancreas (Pharmacy Starter Kit)

Beta Bionics, Inc.

Ambulatory insulin infusion pump/interstitial glucose monitoring system

• Primary Device ID: 00850050080022
• NIH Device Record Key: b9951b12-c1a5-434a-a565-e33c4451f61e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iLet Bionic Pancreas
• Version Model Number: Insulin Only
• Catalog Number: BB1004
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
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• Phone: 855-745-3800
• Email: xx@xx.xx
• 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
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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
• 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	00850050080022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220916

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: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [ iLet Bionic Pancreas]

• 00850050080046: iLet Bionic Pancreas (Commercial Starter Kit)
• 00850050080022: iLet Bionic Pancreas (Pharmacy Starter Kit)
• 00850050080206: iLet Bionic Pancreas (Pharmacy Starter Kit)
• 00850050080183: iLet Bionic Pancreas (Commercial Starter Kit)