Identity
- Trade Name
- Affinity® FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Device Name
- OXYGENATOR CB541 AFFINITY PKGNG ASSY 2PK FDA UDI
- Model / Reference
- CB541 FDA UDI
- Description
- OXYGENATOR CB541 AFFINITY PKGNG ASSY 2PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00721902333880 FDA UDI
- FDA Product Code
- DTZ FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4350 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: Extracorporeal membrane oxygenator
Affinity® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal membrane oxygenator.
- INSPIRE — SORIN GROUP ITALIA SRL · Class II
- Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
- AMG PMP INFANT STERILE — EUROSETS SRL · Class II
- MC3 Nautilus ECMO Oxygenator — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- CAPIOX — Terumo Corp. · Class II
- CAPIOX®RX — Terumo Corp. · Class II
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II
- CAPIOX®FX — Terumo Corp. · Class II
Cleared under the same submission
K000430 also covers:
K191029 also covers:
- AFFINITY® — MEDTRONIC, INC.
- AFFINITY®NT — MEDTRONIC, INC.
- Affinity NT™ — MEDTRONIC, INC.
- Affinity NT™ — MEDTRONIC, INC.
- Affinity NT™ — MEDTRONIC, INC.
- Affinity NT™ — MEDTRONIC, INC.
- Affinity NT™ — MEDTRONIC, INC.
- Affinity NT™ — MEDTRONIC, INC.
- Affinity NT™ — MEDTRONIC, INC.
- Affinity® — MEDTRONIC, INC.
- TRILLIUM® AFFINITY NT® — MEDTRONIC, INC.
- TRILLIUM® AFFINITY NT® — MEDTRONIC, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI b8cdce0b-adab-402f-bb96-21dfc8d2f34e 36 fields · synced May 30, 2026