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: 14500-5A FDA UDI
Primary DI / UDI-DI: 10385081140003 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

Similar devices

Also classified as Ambulatory insulin infusion pump, electronic.

DANA Diabecare — SOOIL DEVELOPMENT CO., LTD · Class II
PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
3.6V Battery — SOOIL DEVELOPMENT CO., LTD · Class II
DANA Diabecare — SOOIL DEVELOPMENT CO., LTD · Class II
PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III
2 Syringe Caps and 2 Battery Caps — SOOIL DEVELOPMENT CO., LTD · Class II
PARADIGM® REAL-time — MEDTRONIC MINIMED, INC. · Class III

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

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

Manufacturer

Manufacturer: Insulet Corporation

Sources (1)

FDA UDI 49436ff9-b4d6-4b7e-96e4-df70deed240c 35 fields · synced Jun 9, 2026