Omnipod

FDA UDI

Class II (US FDA UDI)

by Insulet Corporation

Identity

Trade Name: Omnipod FDA UDI
Generic Name: Ambulatory insulin infusion pump, electronic FDA UDI
Device Name: Eros PDM (Personal Diabetes Manager) FDA UDI
Model / Reference: UST400 FDA UDI
Description: Eros PDM (Personal Diabetes Manager) FDA UDI

Identifiers

Catalog Number: 18900-5A FDA UDI
Primary DI / UDI-DI: 10385081120012 FDA UDI
FDA Product Code: NBW FDA UDI
LZG FDA UDI
NDC FDA UDI
GMDN Term: Ambulatory insulin infusion pump, electronic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
880.5725 FDA UDI
868.1890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump, electronic

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Insulet Corporation

Sources (1)

FDA UDI b792a22a-86cc-4767-ad74-2330a5785b68 35 fields · synced Jun 9, 2026