Capiox® Flexible Venous Reservoir

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name: Capiox® Flexible Venous Reservoir FDA UDI
Generic Name: Cardiotomy reservoir FDA UDI
Model / Reference: 3CXFVR1500XC FDA UDI

Identifiers

Primary DI / UDI-DI: 00699753450202 FDA UDI
510(k) Number: K070839 FDA UDI
FDA Product Code: DTN FDA UDI
GMDN Term: Cardiotomy reservoir FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4400 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: Cardiotomy reservoir

Capiox® Flexible Venous Reservoir by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiotomy reservoir.

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Affinity — MEDTRONIC, INC. · Class II
Intersept™ — MEDTRONIC, INC. · Class II
CAPIOX® VENOUS RESERVOIR — Terumo Corp. · Class II
RESERVOIR — SORIN GROUP ITALIA SRL · Class II
RESERVOIR — SORIN GROUP ITALIA SRL · Class II
Quantum Perfusion Hybrid System — SPECTRUM MEDICAL LIMITED · Class II

Cleared under the same submission

K070839 also covers:

Capiox® Flexible Venous Reservoir — Terumo Cardiovascular Systems Corporation

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 fadc74fa-1766-41bc-8124-279ec10af7bc 33 fields · synced Jun 9, 2026