Perfusion Coupler

GUDID 23700911901052

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.

INSTITUT GEORGES LOPEZ

Kidney donor-organ preservation/transport perfusion set

• Primary Device ID: 23700911901052
• NIH Device Record Key: 16218fd4-255f-430e-b37f-2794afa10826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfusion Coupler
• Version Model Number: PCO25
• Company DUNS: 393146183
• Company Name: INSTITUT GEORGES LOPEZ
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter
• Length: 25 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700911901055 [Primary]
GS1	23700911901052 [Package]; Contains: 13700911901055; Package: Carton Box [25 Units]; In Commercial Distribution
GS1	33700911901059 [Package]; Package: Carton Box [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243998

FDA Product Code

• KDN: System, Perfusion, Kidney

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: 2025-06-03
• Device Publish Date: 2025-05-26

Devices Manufactured by INSTITUT GEORGES LOPEZ

• 13700911900577 - DCX Disposable Cassette: 2025-06-03 The DCX Disposable Cassette is a sterile, disposable and single-use, organ cassette, which is used with a RM4 Control Unit, the
• 23700911901052 - Perfusion Coupler: 2025-06-03The 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.
• 23700911901052 - Perfusion Coupler: 2025-06-03 The Perfusion Coupler shall be used only with the DCX Organ Cassette or the DCM Organ Cassette. This accessory is supplied steri
• 23700911900925 - Perfusion Clamp with Adaptor: 2024-10-28 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
• 23700911900932 - Perfusion Clamp with Adaptor: 2024-10-28 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
• 23700911900949 - Perfusion Clamp with Adaptor: 2024-10-28 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
• 23700911900659 - PARAGON-W (UW solution): 2024-01-01 Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 1L format
• 23700911900666 - PARAGON-W (UW solution): 2024-01-01 Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs of kidney, liver and pancreas. 2L format
• 23700911900628 - Perfusion Clamp: 2023-06-13 The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.