Identity
- Trade Name
- Quantum FDA UDI
- Generic Name
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
- Device Name
- Quantum Centrifugal Emergency Hand Crank High Pressure EUDAMEDCentrifugal Hand Crank for use with CP22 FDA UDI
- Model / Reference
- 52-000027-00 EUDAMEDFDA UDI
- Description
- Centrifugal Hand Crank for use with CP22 FDA UDI
Identifiers
- Catalog Number
- 52-000027-00 FDA UDI
- Primary DI / UDI-DI
- 05060434422132 EUDAMEDFDA UDI
- Basic UDI-DI
- 506043442QCDHC2L EUDAMED
- 510(k) Number
- K192850 FDA UDI
- FDA Product Code
- KFM FDA UDI
- EMDN Code
- Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiopulmonary bypass system centrifugal pump drive unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Cardiopulmonary bypass system centrifugal pump drive unit
Quantum by Spectrum Medical Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spectrum Medical Limited
Sources (2)
- FDA UDI 4fc0fab9-aff7-4f9b-80ec-566e99580147 37 fields · synced Jun 19, 2026
- EUDAMED 98c4cff7-afba-485d-8af6-d675eda2e8fa 61 fields · synced Jun 14, 2026