Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Cardiopulmonary bypass system heating/cooling unit FDA UDI
- Device Name
- Hose Kit - 12.5 mm Bore - 2.5 m long EUDAMEDHose Kit - 12.5mm Bore 2.5m (kit of 2) FDA UDI
- Model / Reference
- 52-000044-00 EUDAMEDFDA UDI
- Description
- Hose Kit - 12.5mm Bore 2.5m (kit of 2) FDA UDI
Identifiers
- Catalog Number
- 52-000044-00 FDA UDI
- Primary DI / UDI-DI
- 05060434422460 EUDAMEDFDA UDI
- Basic UDI-DI
- 506043442QHCHK42 EUDAMED
- FDA Product Code
- DWC FDA UDI
- EMDN Code
- C030199 EXTRACORPOREAL AND ASSISTED CIRCULATION DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiopulmonary bypass system heating/cooling unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4250 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary bypass system heating/cooling unit
Quantum by Spectrum Medical Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system heating/cooling unit.
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- Sarns™ Temperature Control Module — Terumo Cardiovascular Systems Corporation · Class II
- Heater-Cooler System — LivaNova Deutschland GmbH · Class II
- Sarns™ Temperature Probe Module — Terumo Cardiovascular Systems Corporation · Class II
- HX2™ Temperature Management System — Terumo Cardiovascular Systems Corporation · Class II
- CardioQuip Thermoelectric Cooling (TEC) Lid Module — CardioQuip · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spectrum Medical Limited
Sources (2)
- FDA UDI 56fe65ea-31ed-4d51-a3fa-39b8baa2558c 36 fields · synced Aug 1, 2026
- EUDAMED d6ae6e7f-1a3e-42eb-a577-e8bf429968ba 61 fields · synced Aug 1, 2026