OrganOx metra

GUDID 05060462240005

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: 05060462240005
• NIH Device Record Key: 12c6df0d-cf7a-4035-9022-0d6fee6f977f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrganOx metra
• Version Model Number: D0003
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060462240005 [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: false

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

On-Brand Devices [OrganOx metra]

• 05060462240005: D0003
• 05060462240029: The OrganOx metra® is a transportable device intended to be used to sustain donor livers destin