Identity
- Trade Name
- TRILLIUM™ AFFINITY®NT FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Device Name
- RESERVOIR 95249 AFFINITY 4CA CVR-T 540T FDA UDI
- Model / Reference
- 95249 FDA UDI
- Description
- RESERVOIR 95249 AFFINITY 4CA CVR-T 540T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00721902648755 FDA UDI
- 510(k) Number
- K021287 FDA UDI
- FDA Product Code
- DTN FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4400 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
No
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: Extracorporeal membrane oxygenator
Trillium™ Affinity®nt by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extracorporeal membrane oxygenator.
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- CAPIOX — Terumo Corp. · Class II
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- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II
- CAPIOX®FX — Terumo Corp. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 95273909-c795-41e7-872b-326dd80ac9d5 36 fields · synced May 30, 2026