Extension Set

GUDID 19008247000232

Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer. Luer-Lock, bubble trap and injection port.

Biegler GmbH

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• Primary Device ID: 19008247000232
• NIH Device Record Key: 3831ffb7-6bb1-4831-920a-a1c1331710cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extension Set
• Version Model Number: 25000
• Company DUNS: 300451747
• Company Name: Biegler GmbH
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008247000235 [Primary]
GS1	19008247000232 [Package]; Contains: 09008247000235; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121198

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

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: 2024-06-12
• Device Publish Date: 2024-06-04

On-Brand Devices [Extension Set]

• 19008247000843: Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler
• 19008247000249: Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler
• 19008247000232: Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler