Identity
- Trade Name
- Novalung System FDA UDI
- Generic Name
- Cardiopulmonary bypass system blood tubing set FDA UDI
- Device Name
- The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support. FDA UDI
- Model / Reference
- XLung kit FDA UDI
- Description
- The Novalung System, consisting of the Novalung console and XLung kit, is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support. FDA UDI
Identifiers
- Catalog Number
- 32000004 FDA UDI
- Primary DI / UDI-DI
- 04057224001494 FDA UDI
- 510(k) Number
- K191407 FDA UDI
- FDA Product Code
- QJZ FDA UDI
- GMDN Term
- Cardiopulmonary bypass system blood tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4100 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
MR Unsafe FDA UDI
Category: Cardiopulmonary bypass system blood tubing set
Novalung System by Xenios Ag — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass system blood tubing set.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
- Perfusion Pack — LivaNova USA, Inc.
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation
- Perfusion Pack — LivaNova USA, Inc.
Cleared under the same submission
K191407 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
- Xenios Ag
Sources (1)
- FDA UDI 967d1e6e-84b4-45d3-a39f-16b3b0975b8e 35 fields · synced May 30, 2026