Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Cardiopulmonary bypass system roller pump FDA UDI
- Device Name
- Quantum Pump Frame 2 (v2) - Cheltenham (QPF2) EUDAMEDQuantum Pump Frame 2 - Cheltenham FDA UDI
- Model / Reference
- QPF2 EUDAMEDFDA UDI51-000025-01 EUDAMED
- Description
- Quantum Pump Frame 2 - Cheltenham FDA UDI
Identifiers
- Catalog Number
- 51-000025-01 FDA UDI
- Primary DI / UDI-DI
- 05060434422040 EUDAMEDFDA UDI
- Basic UDI-DI
- 506043442QPFE7 EUDAMED
- 510(k) Number
- K173834 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiopulmonary bypass system roller pump FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4220 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
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 roller pump
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 roller pump.
- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
Cleared under the same submission
K173834 also covers:
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
- Quantum — SPECTRUM MEDICAL LIMITED
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 69282a85-ad5a-4a1c-a41d-cda9baa06610 37 fields · synced Jul 17, 2026
- EUDAMED 68a81918-28e1-4ebb-a78d-98ec677996ff 61 fields · synced Jul 17, 2026