Extension Set

GUDID 19008247000843

Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer.

Biegler GmbH

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• Primary Device ID: 19008247000843
• NIH Device Record Key: 936f5ac1-5bb2-47ce-9c25-8f15defba9e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extension Set
• Version Model Number: 46000
• 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	09008247000259 [Primary]
GS1	19008247000843 [Package]; Contains: 09008247000259; Package: [20 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: 2020-06-29
• Device Publish Date: 2020-06-19

Devices Manufactured by Biegler GmbH

• 19008247000843 - Extension Set: 2020-06-29Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer.
• 19008247000843 - Extension Set: 2020-06-29 Disposable product for single use only. Sterile and pyrogen-free flow tube. For use with Biegler blood and infusion warmer.
• 09008247000501 - Blood and Infusion Warmer: 2020-06-29 The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on the basis of a continuous flow warmer, w