Erbe ECO2 plus

FDA UDI

Class II (US FDA UDI)

by Palliare Inc

Identity

Trade Name: Erbe ECO2 plus FDA UDI
Generic Name: Gastrointestinal endoscopic insufflator FDA UDI
Device Name: CO2 Insufflator FDA UDI
Model / Reference: 2N100-068 FDA UDI
Description: CO2 Insufflator FDA UDI

Identifiers

Primary DI / UDI-DI: 05391536920364 FDA UDI
510(k) Number: K230474 FDA UDI
FDA Product Code: FCX FDA UDI
GMDN Term: Gastrointestinal endoscopic insufflator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Gastrointestinal endoscopic insufflator

Erbe ECO2 plus by Palliare Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Protocol Colon Insufflator — Bracco Diagnostics Inc. · Class II
ENDO STRATUS CO2 Insufflator — MEDIVATORS INC. · Class II
IRRIGATOR/INSUFFLATOR — PENTAX of America, Inc. · Class II
Protocol Touch Colon Insufflator — Bracco Diagnostics Inc. · Class II

Cleared under the same submission

K230474 also covers:

EVA 5 Insufflator — PALLIARE INC

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: Palliare Inc

Sources (1)

FDA UDI 0e03af0c-071a-46b9-bb4c-0fb2be68d86f 36 fields · synced May 30, 2026