AccessGUDID - DEVICE: Perfusion Coupler (13700911901055)

GUDID

Device Identifier (DI) Information

Brand Name: Perfusion Coupler
Version or Model: PCO25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSTITUT GEORGES LOPEZ

Primary DI Number: 13700911901055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 393146183 *Terms of Use

Device Description: The Perfusion Coupler shall be used only with the DCX Organ Cassette or the DCM Organ Cassette. This accessory is supplied sterile, disposable and is a single-use device. The Perfusion Coupler has a 25cm length.

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):	No
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?
48039	Kidney donor-organ preservation/transport perfusion set	A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDN	System, Perfusion, Kidney

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243998	000

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
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 25 Centimeter

Device Record Status

Public Device Record Key: 16218fd4-255f-430e-b37f-2794afa10826
Public Version Date: June 03, 2025
Public Version Number: 1
DI Record Publish Date: May 26, 2025