Identity
- Trade Name
- Bionic Circle App, iOS FDA UDI
- Generic Name
- Ambulatory insulin infusion pump software, data-display FDA UDI
- Device Name
- Bionic Circle App, iOS FDA UDI
- Model / Reference
- BOM000082 FDA UDI
- Description
- Bionic Circle App, iOS FDA UDI
Identifiers
- Catalog Number
- BB5001 FDA UDI
- Primary DI / UDI-DI
- 00850050080169 FDA UDI
- FDA Product Code
- PKU FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump software, data-display FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1350 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ambulatory insulin infusion pump software, data-display
Bionic Circle App, iOS 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 software, data-display.
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- t:connect Mobile Application, Mobile Bolus Enabled (Android) — Tandem Diabetes Care, Inc. · Class II
- Omnipod (Dash) Display App. — Insulet Corporation · Class II
- t:connect Mobile Application, Mobile Bolus Enabled (iOS) — Tandem Diabetes Care, Inc. · Class II
- Bionic Circle App, Android — Beta Bionics, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Beta Bionics, Inc.
Sources (1)
- FDA UDI 297948c6-e026-487a-ab18-f748d1c70583 35 fields · synced May 30, 2026