← Back to catalogue
Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2 FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Model / Reference
- VT160-C2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08051160300761 FDA UDI
- 510(k) Number
- K212341 FDA UDI
- FDA Product Code
- DTZ FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Extracorporeal membrane oxygenator
Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2 by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Extracorporeal membrane oxygenator.
- INSPIRE — SORIN GROUP ITALIA SRL · Class II
- Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
- AMG PMP INFANT STERILE — EUROSETS SRL · Class II
- Affinity Fusion® — MEDTRONIC, INC. · Class II
- MC3 Nautilus ECMO Oxygenator — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- CAPIOX — Terumo Corp. · Class II
- CAPIOX®RX — Terumo Corp. · Class II
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II
Cleared under the same submission
K212341 also covers:
- Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2 — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U — 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 9e0f2115-cf3b-4641-ad0c-054e42b7cba4 33 fields · synced May 30, 2026