Waters IGL Pulsatile Perfusion Solution

GUDID 23700911900611

Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of explanted kidneys

INSTITUT GEORGES LOPEZ

Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution Donor-organ/tissue/cell preservation solution

• Primary Device ID: 23700911900611
• NIH Device Record Key: 130152b8-740a-4fa7-8760-f4ce7e4f567b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waters IGL Pulsatile Perfusion Solution
• Version Model Number: PPS/1000
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700911900614 [Primary]
GS1	23700911900611 [Package]; Contains: 13700911900614; Package: Carton box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221386

FDA Product Code

• KDL: Set, Perfusion, Kidney, Disposable

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: 2023-06-01
• Device Publish Date: 2023-05-24

Devices Manufactured by INSTITUT GEORGES LOPEZ

• 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.
• 23700911900635 - 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.
• 23700911900642 - 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.
• 23700911900598 - Waters IGL Cold Storage Solution: 2023-06-01 Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.
• 23700911900604 - Waters IGL Cold Storage Solution: 2023-06-01 Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.
• 23700911900611 - Waters IGL Pulsatile Perfusion Solution: 2023-06-01Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of explanted kidneys
• 23700911900611 - Waters IGL Pulsatile Perfusion Solution: 2023-06-01 Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of exp