Identity
- Trade Name
- NX19 Oxygenator; right-side outlet port FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Model / Reference
- 3CX*NX19E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00699753450981 FDA UDI
- 510(k) Number
- K180950 FDA UDI
- FDA Product Code
- DTZ FDA UDIDTR FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenator FDA UDI
- Models / Variants
- NX19 Oxygenator FDA UDIright-side outlet port FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4350 FDA UDI870.4240 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extracorporeal membrane oxygenator
NX19 Oxygenator +1 more model by Terumo Cardiovascular Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal membrane oxygenator.
- INSPIRE — SORIN GROUP ITALIA SRL · Class II
- AMG PMP INFANT STERILE — EUROSETS SRL · Class II
- Affinity Fusion® — MEDTRONIC, INC. · 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 — Terumo Corp. · Class II
- CAPIOX®FX — Terumo Corp. · Class II
Cleared under the same submission
K180950 also covers:
- NX19 East Sub-Assembly-Japan Only, Export Only — Terumo Cardiovascular Systems Corporation
- NX19 East Sub-Assembly-Japan Only, Export Only — Terumo Cardiovascular Systems Corporation
- NX19 Oxygenator w/4-liter reservoir; left-side outlet port — Terumo Cardiovascular Systems Corporation
- NX19 Oxygenator w/4-liter reservoir; right-side outlet port — Terumo Cardiovascular Systems Corporation
- NX19 Oxygenator; left-side outlet port — Terumo Cardiovascular Systems Corporation
- NX19 Oxygenator; left-side outlet port — Terumo Cardiovascular Systems Corporation
- NX19 Oxygenator; right-side outlet port — Terumo Cardiovascular Systems Corporation
- NX19 West Sub-Assembly-Japan Only, Export Only — Terumo Cardiovascular Systems Corporation
- NX19 West Sub-Assembly-Japan Only, Export Only — Terumo Cardiovascular Systems Corporation
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
- Terumo Cardiovascular Systems Corporation
Sources (1)
- FDA UDI a4f3bd24-e4a3-46b3-badd-f76fbc7401da 33 fields · synced Jun 9, 2026