CELSIOR Cold Storage Solution 533682

GUDID 13700911900126

Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.

INSTITUT GEORGES LOPEZ

Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ preservation solution Donor-organ 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: 13700911900126
• NIH Device Record Key: 24bacde0-da18-4f31-998b-decedd1eb322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELSIOR Cold Storage Solution
• Version Model Number: CELSIOR 1L US
• Catalog Number: 533682
• 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 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700911900126 [Primary]
GS1	23700911900123 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• MSB: System And Accessories, Isolated Heart, Transport And Preservation

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: 2022-02-15
• Device Publish Date: 2022-02-07

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: 2023-06-01 Clear, sterile, non-pyrogenic solution intended for the in-vitro flushing and temporary continuous perfusion preservation of exp