Fresnius Kabi AG

GUDID 00850038863043

18" Standard bore Extension Set with 1.2 Micron Filter, pinch clamp, male luer-lock and female luer

Directmed, Inc.

Intravenous administration tubing extension set

• Primary Device ID: 00850038863043
• NIH Device Record Key: 47cdd8db-05e0-4cdc-a398-6c77ea3d1ed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fresnius Kabi AG
• Version Model Number: FK20255E
• Company DUNS: 969484237
• Company Name: Directmed, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850038863043 [Primary]

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Fresnius Kabi AG]

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• 10850038863057: 30” Minibore Extension Set with slide clamp, male luer-lock and female luer
• 10850038863040: 18" Standard bore Extension Set with 1.2 Micron Filter, pinch clamp, male luer-lock and female
• 10850038863033: 18" Standard bore Extension Set with 0.2 Micron Filter, pinch clamp, male luer-lock and female
• 00850038863067: 60” Minibore Extension Set with slide clamp, male luer-lock and female luer
• 00850038863050: 30” Minibore Extension Set with slide clamp, male luer-lock and female luer
• 00850038863043: 18" Standard bore Extension Set with 1.2 Micron Filter, pinch clamp, male luer-lock and female
• 00850038863036: 18" Standard bore Extension Set with 0.2 Micron Filter, pinch clamp, male luer-lock and female