AccessGUDID - DEVICE: OrganOx metra (05060462240029)

GUDID

Device Identifier (DI) Information

Brand Name: OrganOx metra
Version or Model: D0146
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORGANOX LIMITED

Primary DI Number: 05060462240029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 211154142 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200035	002

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d328a3d-cac2-4b24-a29e-21d28b15d4af
Public Version Date: February 12, 2024
Public Version Number: 2
DI Record Publish Date: February 20, 2023