← Back to catalogue

Omnipod DASH Pod

FDA UDI

Class II (US FDA UDI)

by Insulet Corporation

Identity

Trade Name
Omnipod DASH Pod FDA UDI
Generic Name
Ambulatory insulin infusion pump, electronic FDA UDI
Device Name
DASH Pod FDA UDI
Model / Reference
POD-BLE-11-520 FDA UDI
Description
DASH Pod FDA UDI

Identifiers

Primary DI / UDI-DI
10385082000023 FDA UDI
510(k) Number
K180045 FDA UDI
FDA Product Code
LZG FDA UDI
GMDN Term
Ambulatory insulin infusion pump, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump, electronic

Omnipod DASH Pod by Insulet Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump, electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Insulet Corporation

Sources (1)

  • FDA UDI 9c3a70fa-e8a8-4ee0-8c96-000616ba7246 36 fields · synced Jun 9, 2026