Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Cardiopulmonary bypass system roller pump FDA UDI
- Device Name
- Quantum Pump Frame 3 - Vienna FDA UDI
- Model / Reference
- QPF3 FDA UDI
- Description
- Quantum Pump Frame 3 - Vienna FDA UDI
Identifiers
- Catalog Number
- 51-000056-00 FDA UDI
- Primary DI / UDI-DI
- 05060434420824 FDA UDI
- 510(k) Number
- K173834 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system roller pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4220 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 roller pump
Quantum by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — 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 (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
- Spectrum Medical Limited
Sources (1)
- FDA UDI b165a44b-1685-4f3c-b9c1-c41d68c62519 37 fields · synced Jun 1, 2026