LifePort® Kidney Transporter

GUDID 00815045020001

LifePort® Kidney Transporter 1.0

ORGAN RECOVERY SYSTEMS, INC.

General-purpose donor-organ preservation/transport system General-purpose donor-organ preservation/transport system

• Primary Device ID: 00815045020001
• NIH Device Record Key: c7e5e36c-d57b-4293-b4d4-0b345113bc36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifePort® Kidney Transporter
• Version Model Number: LKT100P
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00815045020001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021362

FDA Product Code

• KDN: System, Perfusion, Kidney

Sterilization

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

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

On-Brand Devices [LifePort® Kidney Transporter]

• 10815045020268: LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (9mm)
• 10815045020244: LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (7mm)
• 20815045020241: LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (5mm)
• 10815045020206: LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (3mm)
• 10815045020183: LifePort® Kidney Transporter Disposable SealRing® Cannula (10x35)
• 10815045020169: LifePort® Kidney Transporter Disposable Coupler
• 10815045020121: LifePort® Kidney Transporter Disposable Straight Cannula (8mm)
• 10815045020107: LifePort® Kidney Transporter Disposable Straight Cannula (5mm)
• 10815045020084: LifePort® Kidney Transporter Disposable Straight Cannula (3mm)
• 00815045020063: LifePort® Kidney Transporter Sterile Drape - Perfusion Pack (Kit)
• 10815045020145: LifePort® Kidney Transporter Disposable SealRing® Cannula (7x20)
• 00815045020049: LifePort® Kidney Transporter Sterile Drape
• 00815045020032: LifePort® Kidney Transporter Perfusion Circuit
• 00815045020025: LifePort® Kidney Transporter Perfusion Pack
• 00815045020018: LifePort® Kidney Transporter 1.1
• 00815045020001: LifePort® Kidney Transporter 1.0