Quantum
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Cardiopulmonary bypass system gas control unit FDA UDI
- Device Name
- Quantum Pump Frame 2 (v2) - Cheltenham (QPF2) EUDAMEDQuantum Pump Frame 7 - Melbourne FDA UDI
- Model / Reference
- QPF2 EUDAMEDQPF7 - part no. 51-000099-00 EUDAMEDQPF7 FDA UDI
- Description
- Quantum Pump Frame 7 - Melbourne FDA UDI
Identifiers
- Catalog Number
- 51-000099-00 FDA UDI
- Primary DI / UDI-DI
- 05060434422514 EUDAMEDFDA UDI
- Basic UDI-DI
- 506043442QPFE7 EUDAMED
- 510(k) Number
- K210669 FDA UDI
- FDA Product Code
- DTX FDA UDI
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiopulmonary bypass system gas control unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Cardiopulmonary bypass system gas control 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 gas control unit.
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
- Quantum — SPECTRUM MEDICAL LIMITED · Class II
Cleared under the same submission
K210669 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 0c8ecb1f-632f-4e88-8a2f-fbbe46fb5d1e 37 fields · synced Jul 10, 2026
- EUDAMED 8c4a5b86-8ed6-4bea-a7af-e5b46b166198 61 fields · synced Jul 10, 2026