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Protek Duo+

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name
PROTEK DUO+ FDA UDI
Generic Name
Mobile extracorporeal gas exchange system catheter kit FDA UDI
Model / Reference
5100-2916 FDA UDI

Identifiers

Primary DI / UDI-DI
08033178019453 FDA UDI
510(k) Number
K232480 FDA UDI
FDA Product Code
PZS FDA UDI
GMDN Term
Mobile extracorporeal gas exchange system catheter kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4100 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: Mobile extracorporeal gas exchange system catheter kit

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

Similar devices

Also classified as Mobile extracorporeal gas exchange system catheter kit.

Cleared under the same submission

K232480 also covers:

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 a414933d-1a64-4daf-88eb-543d09d765f1 33 fields · synced May 30, 2026