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iLet Bionic Pancreas

FDA UDI

Class II (US FDA UDI)

by Beta Bionics, Inc.

Identity

Trade Name
iLet Bionic Pancreas FDA UDI
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI
Device Name
iLet Bionic Pancreas (Commercial Starter Kit) FDA UDI
Model / Reference
Insulin Only FDA UDI
Description
iLet Bionic Pancreas (Commercial Starter Kit) FDA UDI

Identifiers

Catalog Number
BB1002 FDA UDI
Primary DI / UDI-DI
00850050080046 FDA UDI
FDA Product Code
QJI FDA UDI
QFG FDA UDI
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1356 FDA UDI
880.5730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump/interstitial glucose monitoring system

iLet Bionic Pancreas by Beta Bionics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump/interstitial glucose monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beta Bionics, Inc.

Sources (1)

  • FDA UDI 5a63df64-973f-4265-9b01-8b06288598de 35 fields · synced May 30, 2026