Identity
- Trade Name
- AFFINITY®NT FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Device Name
- OXYGENATOR 95213 AFFINITY 2PK 541R FDA UDI
- Model / Reference
- 95213 FDA UDI
- Description
- OXYGENATOR 95213 AFFINITY 2PK 541R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20613994375647 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
Affinity®nt by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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® — MEDTRONIC, INC.
- Affinity® — MEDTRONIC, INC.
- TRILLIUM® AFFINITY NT® — MEDTRONIC, INC.
- TRILLIUM® AFFINITY NT® — MEDTRONIC, INC.
K936003 also covers:
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 ccfc9b40-9cd3-494c-a635-cde3756b60fe 36 fields · synced Jun 1, 2026