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HX2™ Temperature Management System

FDA UDI

Class II (US FDA UDI)

by Terumo Cardiovascular Systems Corporation

Identity

Trade Name
HX2™ Temperature Management System FDA UDI
Generic Name
Cardiopulmonary bypass system heating/cooling unit FDA UDI
Device Name
HX2 Temperature Control System Accessory Hose Kit FDA UDI
Model / Reference
809883 FDA UDI
Description
HX2 Temperature Control System Accessory Hose Kit FDA UDI

Identifiers

Catalog Number
809883 FDA UDI
Primary DI / UDI-DI
00886799000908 FDA UDI
510(k) Number
K071521 FDA UDI
FDA Product Code
DWC FDA UDI
GMDN Term
Cardiopulmonary bypass system heating/cooling unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary bypass system heating/cooling unit

HX2™ Temperature Management System by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system heating/cooling unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Terumo Cardiovascular Systems Corporation

Sources (1)

  • FDA UDI ea5f74c4-7a6a-4688-b2cc-472e1d1ded91 35 fields · synced Jun 9, 2026