prisMaxPrisMax System 955626

GUDID 00085412639499

The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy

BAXTER HEALTHCARE CORPORATION

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Primary Device ID00085412639499
NIH Device Record Key7ac6efe7-9446-478e-bb08-121411d0a7ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameprisMaxPrisMax System
Version Model Number955626
Catalog Number955626
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
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM
Phone+1(800)933-0303
EmailMEDINFO_MEDPRODUCTS@BAXTER.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412639499 [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

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