Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Cardiopulmonary bypass system air bubble/fluid level detector FDA UDI
- Device Name
- Quantum Flow Sensor - ID3/16" x Wall 3/32" (OD3/8") 1.20m FDA UDI
- Model / Reference
- QFS7-ST-120 FDA UDI
- Description
- Quantum Flow Sensor - ID3/16" x Wall 3/32" (OD3/8") 1.20m FDA UDI
Identifiers
- Catalog Number
- 51-000146-00 FDA UDI
- Primary DI / UDI-DI
- 05060434423702 FDA UDI
- 510(k) Number
- K190282 FDA UDI
- FDA Product Code
- DTQ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system air bubble/fluid level detector 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 air bubble/fluid level detector
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 air bubble/fluid level detector.
- MAQUET CARDIOHELP — Maquet Cardiopulmonary AG · 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
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- NEOMED* — Avanos Medical, Inc. · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
- Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
Cleared under the same submission
K190282 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 |
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Manufacturer
- Manufacturer
- Spectrum Medical Limited
Sources (1)
- FDA UDI 3bb1fd25-bbd8-43f5-8cbc-fdacbf2e4b51 37 fields · synced May 30, 2026