High Flow Insufflation Unit

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: HIGH FLOW INSUFFLATION UNIT FDA UDI
Generic Name: Laparoscopic insufflator FDA UDI
Model / Reference: UHI-4 FDA UDI

Identifiers

Catalog Number: N3829642 FDA UDI
Primary DI / UDI-DI: 04953170467219 FDA UDI
510(k) Number: K243527 FDA UDI
FDA Product Code: FCX FDA UDI
HIF FDA UDI
OSV FDA UDI
GMDN Term: Laparoscopic insufflator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
884.1730 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laparoscopic insufflator

High Flow Insufflation Unit by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Laparoscopic insufflator.

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High pressure tube CO2 DIN:US — W.O.M. World of Medicine GmbH · Class I
CO2 gas connecter, angled — W.O.M. World of Medicine GmbH · Class I

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: Olympus Medical Systems Corporation

Sources (1)

FDA UDI 38984340-6464-4c7f-b23f-75e5713a4d5b 35 fields · synced May 30, 2026