Leukoconnect 4C4300

GUDID 14052682004305

LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution

Fresenius Kabi AG

Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set

• Primary Device ID: 14052682004305
• NIH Device Record Key: d39bbd14-5202-4037-b250-7c0952610f3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leukoconnect
• Version Model Number: 4C4300
• Catalog Number: 4C4300
• 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: false
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811137010486 [Previous]
GS1	04052682004308 [Primary]
GS1	14052682004305 [Package]; Contains: 04052682004308; Package: Carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK020008

FDA Product Code

• CAK: Microfilter, Blood Transfusion

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: 2022-06-10
• Device Publish Date: 2022-06-02

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