OrganOx metra

GUDID 05060462240029

The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.

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

• Primary Device ID: 05060462240029
• NIH Device Record Key: 2d328a3d-cac2-4b24-a29e-21d28b15d4af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrganOx metra
• Version Model Number: D0146
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060462240029 [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: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [OrganOx metra]

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