AMICUS Exchange Kit X6R2339

GUDID 04086000100151

For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.

Fresenius Kabi AG

Therapeutic plasma/red blood cell exchange tubing set

• Primary Device ID: 04086000100151
• NIH Device Record Key: 00c008cf-c68d-4a80-abb8-da5b90a910a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMICUS Exchange Kit
• Version Model Number: X6R2339
• Catalog Number: X6R2339
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000100151 [Primary]
GS1	14086000100158 [Package]; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111702

FDA Product Code

• LKN: Separator, Automated, Blood Cell And Plasma, Therapeutic

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: 2016-09-05

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