KPS-1®

GUDID 10815045020343

KPS-1®, Machine Preservation Solution (1 Liter)

ORGAN RECOVERY SYSTEMS, INC.

Donor-organ preservation solution

• Primary Device ID: 10815045020343
• NIH Device Record Key: 1a10329f-4f77-4b0b-88ec-727b481015b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KPS-1®
• Version Model Number: KPS-1
• Company DUNS: 078972580
• Company Name: ORGAN RECOVERY SYSTEMS, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815045020346 [Primary]
GS1	10815045020343 [Package]; Contains: 00815045020346; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022391

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: 2017-10-16

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