Device
The Cannulation Set provide a connection between an explanted organ and an Organ Perfusion System. Particular compatibility is claimed with the Organ Perfusion System RM4.
Manufacturer
INSTITUT GEORGES LOPEZ
INSTITUT GEORGES LOPEZ
Model: PCAN3
DI: 13700911901000
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
The Cannulation Set provide a connection between an explanted organ and an Organ Perfusion System. Particular compatibility is claimed with the Organ Perfusion System RM4.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0b54ecdf-001e-417b-8e16-2bffddf57661
Distribution Status:
In Commercial Distribution
DUNS Number:
393146183
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Secondary
Item #1 - Device ID:
23700911901007
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
6
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
13700911901000
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
13700911901000
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Tertiary
Item #3 - Device ID:
33700911901004
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
90
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
23700911901007
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 48039
Name: Kidney donor-organ preservation/transport perfusion set
Definition:
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.
FDA Product Codes
KDN
System, Perfusion, Kidney
Premarket Submissions
Submission Number:
K211224
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Millimeter
Device Size - Size - @attributes - Value:
3
Device Size - Size Type:
Lumen/Inner Diameter
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature