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Protek Solo

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name
PROTEK SOLO FDA UDI
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI
Model / Reference
5140-6024 FDA UDI

Identifiers

Primary DI / UDI-DI
08033178019323 FDA UDI
510(k) Number
K162214 FDA UDI
FDA Product Code
DWF FDA UDI
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

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

Similar devices

Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sorin Group Italia Srl

Sources (1)

  • FDA UDI fdbd3ea1-5f4f-4d89-90a9-1c0e586230b4 33 fields · synced May 30, 2026