Belzer MPS (UW Machine Perfusion Solution )

GUDID 10810805000092

Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL

PRESERVATION SOLUTIONS INC

Donor-organ preservation solution

• Primary Device ID: 10810805000092
• NIH Device Record Key: d4ab21f5-8561-489d-8192-aaef9cf35ab2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Belzer MPS (UW Machine Perfusion Solution )
• Version Model Number: MPS-001
• 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	00810805000095 [Primary]
GS1	10810805000092 [Package]; Contains: 00810805000095; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080432

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-22

On-Brand Devices [Belzer MPS (UW Machine Perfusion Solution )]

• 10810805000108: Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation o
• 10810805000092: Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation o