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Omnipod DASH PDM

FDA UDI

Class II (US FDA UDI)

by Insulet Corporation

Identity

Trade Name
Omnipod DASH PDM FDA UDI
Generic Name
Ambulatory insulin infusion administration unit/remote control system FDA UDI
Device Name
PDM mg/dL - DASH, English FDA UDI
Model / Reference
PDM-USA1-D001-MG-USA1 FDA UDI
Description
PDM mg/dL - DASH, English FDA UDI

Identifiers

Primary DI / UDI-DI
10385082000009 FDA UDI
510(k) Number
K211575 FDA UDI
FDA Product Code
LZG FDA UDI
NDC FDA UDI
GMDN Term
Ambulatory insulin infusion administration unit/remote control system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
868.1890 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory insulin infusion administration unit/remote control system

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Insulet Corporation

Sources (1)

  • FDA UDI cd3ecb07-6694-45c4-99da-8c83dcb30663 35 fields · synced Jun 9, 2026