Waters IGL Cold Storage Solution

GUDID 10810805000153

Formulated for flushing and cold storage of kidney, liver and pancreas organs. 1000 mL

PRESERVATION SOLUTIONS INC

Donor-organ preservation solution

• Primary Device ID: 10810805000153
• NIH Device Record Key: f188eda8-dddb-4b87-b0b9-0df6605487bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waters IGL Cold Storage Solution
• Version Model Number: CSS/1000/US
• Company DUNS: 090266979
• Company Name: PRESERVATION SOLUTIONS INC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810805000156 [Primary]
GS1	10810805000153 [Package]; Contains: 00810805000156; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-22

On-Brand Devices [Waters IGL Cold Storage Solution]

• 10810805000160: Formulated for flushing and cold storage of kidney, liver and pancreas organs. 2000 mL
• 10810805000153: Formulated for flushing and cold storage of kidney, liver and pancreas organs. 1000 mL