PLASMACELL Xi Disposable Set with SPIKESMART 6R2600P

GUDID 10810020441113

For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.

Fresenius Kabi AG

Apheresis system tubing set

• Primary Device ID: 10810020441113
• NIH Device Record Key: 7c3dc94f-76a5-4c99-8977-923913be4072
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLASMACELL Xi Disposable Set with SPIKESMART
• Version Model Number: 6R2600P
• Catalog Number: 6R2600P
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Protect from freezing. Avoid excessive heat.
• 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	00810020441116 [Primary]
GS1	10810020441113 [Package]; Contains: 00810020441116; Package: Carton [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK160028

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-06
• Device Publish Date: 2023-02-24

On-Brand Devices [PLASMACELL Xi Disposable Set with SPIKESMART]

• 04086000101097: For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile
• 10810020441113: For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile