metra Liver Perfusion Circuit Pack

Basic Information

• Brand Name: metra Liver Perfusion Circuit Pack
• Primary DI: 05060462240043
• Version / Model: D0146_US
• Company Name: ORGANOX LIMITED
• Labeler DUNS: 211154142
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-15
• Public Version: 3
• Public Version Date: 2024-02-12
• Public Version Status: Update
• Public Device Record Key: db0afd20-7477-4cc0-aea3-b01732f649a6

Device Description

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 macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
42919	Liver donor-organ preservation/transport system	A dedicated system designed to support and maintain a donated liver organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060462240043	GS1

Premarket Submissions

Submission Number	Supplement Number
P200035	002

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius