AccessGUDID - DEVICE: Novalung System (04057224902043)

GUDID

Device Identifier (DI) Information

Brand Name: Novalung System
Version or Model: Novalung console
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30000162
Company Name: XENIOS AG

Primary DI Number: 04057224902043
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:	No
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?
33317	Cardiopulmonary bypass system centrifugal pump drive unit	A mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.	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: No
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: 1c584ccd-bdb4-4ae5-90e6-a605d413a965
Public Version Date: December 25, 2020
Public Version Number: 1
DI Record Publish Date: December 17, 2020