Primo2x

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name: PRIMO2X FDA UDI
Generic Name: Extracorporeal membrane oxygenator FDA UDI
Model / Reference: PRIMO2X FDA UDI

Identifiers

Primary DI / UDI-DI: 08033178100687 FDA UDI
510(k) Number: K050447 FDA UDI
FDA Product Code: DTZ FDA UDI
GMDN Term: Extracorporeal membrane oxygenator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4350 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: Extracorporeal membrane oxygenator

Primo2x by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal membrane oxygenator.

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Affinity Fusion® — MEDTRONIC, INC. · Class II
MC3 Nautilus ECMO Oxygenator — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
CAPIOX — Terumo Corp. · Class II
CAPIOX®RX — Terumo Corp. · Class II
Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II
CAPIOX®FX — Terumo Corp. · Class II

Cleared under the same submission

K050447 also covers:

PRIMO2X — SORIN GROUP ITALIA SRL

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 367ea14d-a142-4014-90b3-f8969f13c271 33 fields · synced May 31, 2026