ALYX™ RBC/Plasma Kit 4R5700

GUDID 00811137010134

For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.

FENWAL, INC.

Apheresis system tubing set

• Primary Device ID: 00811137010134
• NIH Device Record Key: 3ac7ab07-3852-4e49-b124-25881aa5bf12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALYX™ RBC/Plasma Kit
• Version Model Number: 4R5700
• Catalog Number: 4R5700
• Company DUNS: 794519020
• Company Name: FENWAL, 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137010134 [Primary]
GS1	10811137010131 [Package]; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK040084

FDA Product Code

• GKT: Separator, Automated, Blood Cell, Diagnostic

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: 2016-09-08

Devices Manufactured by FENWAL, INC.

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• 20811137010657 - NA: 2019-11-08 Plasma Transfer Sets with Spike and Male Luer Adapter. Sterile Fluid Path
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