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Omnipod 5 Controller APP

FDA UDI

Class II (US FDA UDI)

by Insulet Corporation

Identity

Trade Name
Omnipod 5 Controller APP FDA UDI
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI
Device Name
Omnipod 5 Controller APP FDA UDI
Model / Reference
M009-S-AP FDA UDI
Description
Omnipod 5 Controller APP FDA UDI

Identifiers

Primary DI / UDI-DI
10385083000336 FDA UDI
FDA Product Code
QRX FDA UDI
QJI FDA UDI
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1358 FDA UDI
862.1356 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

Yes

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

No

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/interstitial glucose monitoring system

Omnipod 5 Controller APP by Insulet Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump/interstitial glucose monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insulet Corporation

Sources (1)

  • FDA UDI b607ec5f-3be5-4f59-8fdc-432b95148344 34 fields · synced Jun 9, 2026