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Xtra

FDA UDI

Class II (US FDA UDI)

by LivaNova Deutschland GmbH

Identity

Trade Name
XTRA FDA UDI
Generic Name
Autotransfusion system blood collection/processing pump FDA UDI
Model / Reference
100-120V FDA UDI

Identifiers

Primary DI / UDI-DI
04033817752219 FDA UDI
510(k) Number
K131553 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Autotransfusion system blood collection/processing pump FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Autotransfusion system blood collection/processing pump

Xtra by LivaNova Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Autotransfusion system blood collection/processing pump.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LivaNova Deutschland GmbH

Sources (1)

  • FDA UDI fc90e971-534d-4a48-b6a2-3d998c439b5a 33 fields · synced May 31, 2026