Insufflator 50L

FDA UDI

Class II (US FDA UDI)

by W.O.M. World of Medicine GmbH

Identity

Trade Name: Insufflator 50L FDA UDI
Generic Name: Laparoscopic insufflator FDA UDI
Model / Reference: FM134 FDA UDI

Identifiers

Primary DI / UDI-DI: 04056702003227 FDA UDI
510(k) Number: K153513 FDA UDI
FDA Product Code: HIF FDA UDI
GMDN Term: Laparoscopic insufflator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

Insufflator 50L by W.O.M. World of Medicine GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: W.O.M. World of Medicine GmbH

Sources (1)

FDA UDI fbd7dbc0-0eee-4c24-822a-a0348ac7ef60 33 fields · synced May 30, 2026