sLA Membrane Lung 8800076

GUDID 04260058550711

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.

novalung GmbH

Extracorporeal membrane oxygenator

• Primary Device ID: 04260058550711
• NIH Device Record Key: 64b61b85-ba44-40aa-9e82-943f7273e039
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: sLA Membrane Lung
• Version Model Number: Novalung® Surgical Lung Assist (sLA) MembraneLung
• Catalog Number: 8800076
• Company DUNS: 331791694
• Company Name: novalung GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49713127060
• Email: info@novalung.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260058550711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072362

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-13
• Device Publish Date: 2015-09-30

Devices Manufactured by novalung GmbH

• 04260058550711 - sLA Membrane Lung: 2020-02-13The 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.
• 04260058550711 - sLA Membrane Lung: 2020-02-13 The Novalung sLA Membrane Lung is a gas exchange device that allows for oxygen and carbon dioxide gas exchange to occur by diffu
• 04260058550728 - NovaPort cannula: 2018-07-06 The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where t
• 04260058550735 - NovaPort cannula: 2018-07-06 The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where t
• 04260058550742 - NovaPort cannula: 2018-07-06 The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where t
• 04260058550759 - NovaPort cannula: 2018-07-06 The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where t