Identity
- Trade Name
- Affinity™ FDA UDI
- Generic Name
- Cardiopulmonary bypass system filter, arterial blood line FDA UDI
- Device Name
- FILTER CB851 AF100 WITH CORTIVA 26L FDA UDI
- Model / Reference
- CB851 FDA UDI
- Description
- FILTER CB851 AF100 WITH CORTIVA 26L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169878112 FDA UDI
- 510(k) Number
- K123351 FDA UDI
- FDA Product Code
- DTM FDA UDI
- GMDN Term
- Cardiopulmonary bypass system filter, arterial blood line FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4260 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary bypass system filter, arterial blood line
Affinity™ by Medtronic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system filter, arterial blood line.
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- MICRO — SORIN GROUP ITALIA SRL · Class II
- CAPIOX®ARTERIAL FILTER — Terumo Corp. · Class II
- MICRO — SORIN GROUP ITALIA SRL · Class II
- MICRO — SORIN GROUP ITALIA SRL · Class II
- FILTER, GAS/OXYGEN — NOVOSCI CORP. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Medtronic, Inc.
Sources (2)
- FDA UDI b1eafd01-e2e9-40c5-a353-310f1a60753a 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026