Kidney Assist Transport 23.101

GUDID 08719925460517

The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the preservation, transport, and eventual transplantation into a recipient.

XVIVO B.V.

Kidney donor-organ preservation/transport system

• Primary Device ID: 08719925460517
• NIH Device Record Key: 0bf747b9-fd1a-4892-b6e0-c3234dbf16d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kidney Assist Transport
• Version Model Number: Kidney Assist Transport
• Catalog Number: 23.101
• Company DUNS: 489176113
• Company Name: XVIVO B.V.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com
• Phone: +310503131905
• Email: info.xnl@xvivogroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719925460517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211333

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-12
• Device Publish Date: 2022-05-04

Devices Manufactured by XVIVO B.V.

• 08719925460517 - Kidney Assist Transport: 2022-05-12The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the preservation, transport, and eventual transplantation into a recipient.
• 08719925460517 - Kidney Assist Transport: 2022-05-12 The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the
• 08719925460524 - Kidney Assist Transport Perfusion set: 2022-05-12 The KIDNEY ASSIST-transport is intended to be used for the pulsatile hypothermic oxygenated machine perfusion of kidneys for the