metra Liver Perfusion Circuit Pack

GUDID 05060462240043

ORGANOX LIMITED

Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system Liver donor-organ preservation/transport system

• Primary Device ID: 05060462240043
• NIH Device Record Key: db0afd20-7477-4cc0-aea3-b01732f649a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: metra Liver Perfusion Circuit Pack
• Version Model Number: D0146_US
• Company DUNS: 211154142
• Company Name: ORGANOX LIMITED
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060462240043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200035

FDA Product Code

• QQK: Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-23
• Device Publish Date: 2022-06-15

Devices Manufactured by ORGANOX LIMITED

• 05060462240029 - OrganOx metra: 2023-02-28 The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a func
• 05060462240005 - OrganOx metra: 2022-06-23
• 05060462240043 - metra Liver Perfusion Circuit Pack: 2022-06-23
• 05060462240043 - metra Liver Perfusion Circuit Pack: 2022-06-23