Skip to content

iLet Starter Kit Insulin Only

by Beta Bionics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850050080374 UDI-DI Date11 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
iLet Starter Kit
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system
Model / Ref / Catalog
Insulin Only, BB1018
Primary DI / UDI-DI
00850050080374
FDA Product Code
QJI, QFG, FPA, FMF, FMI, JKA
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring system
Device Class
Class II
Regulation Number
862.1356, 880.5730, 880.5440, 880.5860, 880.5570, 862.1675
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Beta Bionics, Inc.

See all devices from Beta Bionics, Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No