Xtra

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name: XTRA FDA UDI
Generic Name: Disposable vacuum tubing FDA UDI
Model / Reference: VACUUM EXTENSION LINE FDA UDI

Identifiers

Primary DI / UDI-DI: 08033178113755 FDA UDI
510(k) Number: K241236 FDA UDI
FDA Product Code: CAC FDA UDI
DTN FDA UDI
GMDN Term: Disposable vacuum tubing FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5830 FDA UDI
870.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Disposable vacuum tubing

Xtra by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Disposable vacuum tubing.

ProCure — Twin Med, LLC · Class II
Tube set for vacuum incl. filter, 30-day use — W.O.M. World of Medicine GmbH · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
KAMVAC — DEPUY ORTHOPAEDICS, INC. · Class II
KAMVAC — DEPUY ORTHOPAEDICS, INC. · Class II
Tube set for suction, single-use — W.O.M. World of Medicine GmbH · Class II
Vacuum Pump Tubing — Vitrolife Sweden AB · Class II
Prabadin — Prabadin Corp · Class II

Cleared under the same submission

K241236 also covers:

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: Sorin Group Italia Srl

Sources (1)

FDA UDI 0bd98b27-fd67-44e0-90a7-ef7a6eda9ef7 33 fields · synced Jun 1, 2026