therMaxTherMax Blood Warmer 955630

GUDID 00085412639505

The TherMax blood warmer is an accessory device intended for use with the PrisMax system and appropriate blood warmer compatible Prismaflex sets for the therapy in use. The blood warmer heats the return blood flow during a PrisMax system treatment in order to replace heat lost to the atmosphere and replacement fluids.

BAXTER HEALTHCARE CORPORATION

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• Primary Device ID: 00085412639505
• NIH Device Record Key: ca1bf7e1-b828-4617-b975-21cf61b61240
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: therMaxTherMax Blood Warmer
• Version Model Number: 955630
• Catalog Number: 955630
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(800)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412639505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190910

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

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: 2020-02-10
• Device Publish Date: 2020-01-31

On-Brand Devices [therMaxTherMax Blood Warmer]

• 37332414123933: The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in com
• 00085412639505: The TherMax blood warmer is an accessory device intended for use with the PrisMax system and app