Identity
- Trade Name
- KIT Quantum SuperPAC Tubing Set - 200R FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Model / Reference
- SPC-200R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28051160302509 FDA UDI
- 510(k) Number
- K213540 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set 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
Yes
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
Category: Cardiopulmonary bypass system blood tubing set
KIT Quantum SuperPAC Tubing Set - 200R by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system blood tubing set.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
Cleared under the same submission
K213540 also covers:
- KIT Quantum SuperPAC Tubing Set - 160R — SPECTRUM MEDICAL LIMITED
- Quantum Perfusion SuperPAC Tubing set - SP05E-AA — SPECTRUM MEDICAL LIMITED
- Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B1 — SPECTRUM MEDICAL LIMITED
- Quantum SuperPAC Tubing set - SP08C-AA — SPECTRUM MEDICAL LIMITED
- Quantum SuperPAC Tubing set - SP09C-AA — SPECTRUM MEDICAL LIMITED
- Quantum SuperPAC Tubing set - SP09C-DA — 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 65e42897-bb55-400b-bbd5-b72910e2ca3f 33 fields · synced May 30, 2026