Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name: Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. FDA UDI
Generic Name: Extracorporeal membrane oxygenator FDA UDI
Model / Reference: 3CX*FX15RW40C FDA UDI

Identifiers

Primary DI / UDI-DI: 00699753450790 FDA UDI
FDA Product Code: DTN FDA UDI
DTZ FDA UDI
DTM FDA UDI
DTR FDA UDI
GMDN Term: Extracorporeal membrane oxygenator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4400 FDA UDI
870.4350 FDA UDI
870.4260 FDA UDI
870.4240 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

Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA…

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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: Terumo Cardiovascular Systems Corporation

Sources (1)

FDA UDI 67d593b8-2dfa-4adc-8077-245171f24c55 32 fields · synced Jun 9, 2026