Reservoir

FDA UDI

Class II (US FDA UDI)

by Sorin Group Italia Srl

Identity

Trade Name: RESERVOIR FDA UDI
Generic Name: Cardiotomy reservoir FDA UDI
Model / Reference: D764 DIDECO MIDICARD FDA UDI

Identifiers

Primary DI / UDI-DI: 08033178250252 FDA UDI
510(k) Number: K941215 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

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

Similar devices

Also classified as Cardiotomy reservoir.

Affinity — MEDTRONIC, INC. · Class II
Intersept™ — MEDTRONIC, INC. · Class II
CAPIOX® VENOUS RESERVOIR — Terumo Corp. · Class II
Capiox® Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
Quantum Perfusion Hybrid System — SPECTRUM MEDICAL LIMITED · Class II
Intersept® — MEDTRONIC, INC. · Class II
CAPIOX® VENOUS RESERVOIR — Terumo Corp. · Class II
Capiox® Flexible Venous Reservoir — Terumo Cardiovascular Systems Corporation · Class II

Cleared under the same submission

K941215 also covers:

RESERVOIR — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sorin Group Italia Srl

Sources (1)

FDA UDI f9a904b1-f35f-43f7-9441-2689b3e36cfb 33 fields · synced May 30, 2026