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

Conduction blood/fluid warmer
Primary Device ID00085412639505
NIH Device Record Keyca1bf7e1-b828-4617-b975-21cf61b61240
Commercial Distribution StatusIn Commercial Distribution
Brand NametherMaxTherMax Blood Warmer
Version Model Number955630
Catalog Number955630
Company DUNS005083209
Company NameBAXTER HEALTHCARE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412639505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

On-Brand Devices [therMaxTherMax Blood Warmer]

37332414123933The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.
00085412639505The 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.

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