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

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• 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