Blood and Infusion Warmer

GUDID 09008247000501

The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on the basis of a continuous flow warmer, where the heat from the heat exchanger is transferred via the extension sets (consumables) to the liquid flowing within it.

Biegler GmbH

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• Primary Device ID: 09008247000501
• NIH Device Record Key: a6c3749c-8004-431a-adb0-cd33b9f62d95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood and Infusion Warmer
• Version Model Number: BW 685
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	09008247000501 [Primary]

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: false

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: 2020-06-29 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: 2020-06-29The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on the basis of a continuous flow warmer, where the heat from the heat exchanger is transferred via the extension sets (consumables) to the liquid flowing within it.
• 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