Skip to content

iLet Insulin Infusion Kit Insulin Only

by Beta Bionics, Inc. 2 variants

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 Number00850050080381 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  • Withdrawn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 Insulin Infusion Kit
Generic Name
Electric infusion pump administration set, single-use
Model / Ref / Catalog
Insulin Only, BB1019
Primary DI / UDI-DI
00850050080381
FDA Product Code
QFG, FPA, FMF, FMI, JKA
GMDN Term
Electric infusion pump administration set, single-use
Device Class
Class II
Regulation Number
880.5730, 880.5440, 880.5860, 880.5570, 862.1675
GUDID distribution status
In Commercial Distribution

Other devices from Beta Bionics, Inc.

See all devices from Beta Bionics, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No