Identity
- Trade Name
- Quantum Perfusion Dual Lumen Cannula 31F-VS FDA UDI
- Generic Name
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI
- Model / Reference
- DL31F-VS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08051160301713 FDA UDI
- 510(k) Number
- K221353 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Quantum Perfusion Dual Lumen Cannula 31F-VS by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage.
- Bio-Medicus™ — MEDTRONIC, INC. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Venous Cannula — SORIN GROUP ITALIA SRL · Class II
- VC2™ — MEDTRONIC, INC. · Class II
- DLP™ — MEDTRONIC, INC. · Class II
- Venous cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- MC2™ — MEDTRONIC, INC. · Class II
Cleared under the same submission
K221353 also covers:
- Quantum Perfusion Dual Lumen Cannula 24F — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Dual Lumen Cannula 24F-V1 — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Dual Lumen Cannula 27 — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Dual Lumen Cannula 27F-V1 — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Dual Lumen Cannula 27F-VS — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Dual Lumen Cannula 29F — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Dual Lumen Cannula 29F-V1 — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion Dual Lumen Cannula 31F — 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 |
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Manufacturer
- Manufacturer
- Spectrum Medical Limited
Sources (1)
- FDA UDI c4dc784c-0a09-4cb2-8679-547ac58f1802 33 fields · synced May 30, 2026