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Omnipod 5 Controller APP M009-2S-AP

by Insulet Corporation

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10385083000459 UDI-DI Date1 Dec 2025ListedStatusListed 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  • Withdrawn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
Omnipod 5 Controller APP
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system
Model / Reference
M009-2S-AP
Primary DI / UDI-DI
10385083000459
FDA Product Code
QRX, QJI
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring system
Device Class
Class II
Regulation Number
862.1358, 862.1356
GUDID distribution status
In Commercial Distribution

Other devices from Insulet Corporation

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Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No