AccessGUDID - DEVICE: Novalung System (04057224001494)

GUDID

Device Identifier (DI) Information

Brand Name: Novalung System
Version or Model: XLung kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32000004
Company Name: XENIOS AG

Primary DI Number: 04057224001494
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341858364 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35441	Cardiopulmonary bypass system blood tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191407	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 967d1e6e-84b4-45d3-a39f-16b3b0975b8e
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: December 17, 2020