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Omnipod (Dash) Display App.

FDA UDI

Class II (US FDA UDI)

by Insulet Corporation

Identity

Trade Name
Omnipod (Dash) Display App. FDA UDI
Generic Name
Ambulatory insulin infusion pump software, data-display FDA UDI
Device Name
Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252 FDA UDI
Model / Reference
1.3.1 FDA UDI
Description
Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252 FDA UDI

Identifiers

Catalog Number
18239 FDA UDI
Primary DI / UDI-DI
10385081120265 FDA UDI
FDA Product Code
PKU FDA UDI
GMDN Term
Ambulatory insulin infusion pump software, data-display FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1350 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

No

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

Yes

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 software, data-display

Omnipod (Dash) Display 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 software, data-display.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insulet Corporation

Sources (1)

  • FDA UDI 2f4cb276-8c75-4958-880a-83cc0bcd4460 35 fields · synced Jun 9, 2026