AccessGUDID - DEVICE: sLA Membrane Lung (04260058550711)

GUDID

Device Identifier (DI) Information

Brand Name: sLA Membrane Lung
Version or Model: Novalung® Surgical Lung Assist (sLA) MembraneLung TM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8800076
Company Name: novalung GmbH

Primary DI Number: 04260058550711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 331791694 *Terms of Use

Device Description: The Novalung sLA Membrane Lung is a gas exchange device that allows for oxygen and carbon dioxide gas exchange to occur by diffusion across a polymethylpentene (PMP) hollow fibre membrane material. Used in conjunction with a heart-lung machine along with a separate venous reservoir and heat exchanger, the sLA Membrane Lung can be used in open-heart surgery.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Extracorporeal membrane oxygenator	A device designed for the extracorporeal diffusion of oxygen into the blood across a gas-permeable membrane used mainly during long-term surgery involving heart-lung bypass systems. It includes a membrane made of microporous polypropylene that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The hollow-fibre membrane oxygenator is the most common design and uses thousands of polypropylene or polyethylene (PE) capillary tubes to provide the blood/gas barrier. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Extracorporeal membrane oxygenator

A device designed for the extracorporeal diffusion of oxygen into the blood across a gas-permeable membrane used mainly during long-term surgery involving heart-lung bypass systems. It includes a membrane made of microporous polypropylene that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The hollow-fibre membrane oxygenator is the most common design and uses thousands of polypropylene or polyethylene (PE) capillary tubes to provide the blood/gas barrier. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
DTZ	Oxygenator, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072362	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

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Storage and Handling
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 0,5-4,5 liter per minute

Device Record Status

Public Device Record Key: 64b61b85-ba44-40aa-9e82-943f7273e039
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 30, 2015