ALYX Component Collection System 6R5725

GUDID 04086000100212

Intended for use in blood collection establishments to collect and separate whole blood into its components.

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 04086000100212
• NIH Device Record Key: 34600ecc-0497-4fd9-b490-3873d9d3ef0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALYX Component Collection System
• Version Model Number: 6R5725
• Catalog Number: 6R5725
• 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: 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	04086000100212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK010033

FDA Product Code

• GKT: Separator, Automated, Blood Cell, Diagnostic

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: 2016-09-08

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