Identity
- Trade Name
- iLet Insulin Infusion Kit – Inset™ (32") 10-Pack FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- Pharmacy kit for use with the iLet Bionic Pancreas FDA UDI
- Model / Reference
- Insulin Only FDA UDI
- Description
- Pharmacy kit for use with the iLet Bionic Pancreas FDA UDI
Identifiers
- Catalog Number
- BB4313 FDA UDI
- Primary DI / UDI-DI
- 00850050080008 FDA UDI
- FDA Product Code
- QFG FDA UDIFPA FDA UDIFMF FDA UDIFMI FDA UDIJKA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5730 FDA UDI880.5440 FDA UDI880.5860 FDA UDI880.5570 FDA UDI862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hypodermic needle, single-useGeneral-purpose syringe, single-useElectric infusion pump administration set, single-useLuer/Luer linear connector, single-use
iLet Insulin Infusion Kit – Inset™ (32") 10-Pack by Beta Bionics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 89bde328-4e68-4aa6-a8c8-f38dca703fcf 35 fields · synced Jun 1, 2026