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Quantum PureFlow KIT CPC - Barbed Connector Adaptor
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Quantum PureFlow KIT CPC - Barbed Connector Adaptor FDA UDI
- Generic Name
- Cardiopulmonary bypass system heat exchanger, single-use FDA UDI
- Model / Reference
- CONN-HX1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08051160301560 FDA UDI
- FDA Product Code
- KRI FDA UDI
- GMDN Term
- Cardiopulmonary bypass system heat exchanger, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4200 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
Yes
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 heat exchanger, single-use
Quantum PureFlow KIT CPC - Barbed Connector Adaptor by Spectrum Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system heat exchanger, single-use.
- CAPIOX — Terumo Corp. · Class II
- Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W — SPECTRUM MEDICAL LIMITED · Class II
- Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 — SPECTRUM MEDICAL LIMITED · Class II
- Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 - PL — SPECTRUM MEDICAL LIMITED · Class II
- Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 - PL — SPECTRUM MEDICAL LIMITED · Class II
- Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 — SPECTRUM MEDICAL LIMITED · Class II
- Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 — SPECTRUM MEDICAL LIMITED · Class II
- Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M — SPECTRUM MEDICAL LIMITED · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Spectrum Medical Limited
Sources (1)
- FDA UDI 1aa4cccc-bc82-4bab-8e82-7ee8e68c2def 32 fields · synced May 30, 2026