Waters IGL Cold Storage Solution

GUDID 23700911900598

Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney, liver and pancreas.

INSTITUT GEORGES LOPEZ

Donor-organ/tissue/cell preservation solution

• Primary Device ID: 23700911900598
• NIH Device Record Key: 5b593c53-a4c3-441d-9148-897f13d331b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waters IGL Cold Storage Solution
• Version Model Number: CSS/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
• 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	13700911900591 [Primary]
GS1	23700911900598 [Package]; Contains: 13700911900591; Package: Carton box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221387

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

On-Brand Devices [Waters IGL Cold Storage Solution]

• 23700911900604: Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney,
• 23700911900598: Clear, sterile, non-pyrogenic solution intended for hypothermic flushing and storage of kidney,