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

Haemodialysis system, institutional
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
Email[email protected]

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

Devices Manufactured by BAXTER HEALTHCARE CORPORATION

00085412639505 - therMaxTherMax Blood Warmer2020-02-10 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.
00085412639499 - prisMaxPrisMax System2020-02-10The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
00085412639499 - prisMaxPrisMax System2020-02-10 The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
37332414123933 - therMaxTherMax Blood Warmer2020-02-10 The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.
50085412656644 - CLEARLINK2019-12-11 CLEARLINK System. Non-DEHP Solution Set with DUO-VENT Spike
50085412007699 - MINICAP WITH POVIDONE-IODINE SOLUTION2019-11-12 This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
50085412645822 - PRISMASATE2019-11-04 The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
50085412565700 - CLEARLINK/BURETROL2019-10-08 Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar
05413765577369 - ABACUS2019-07-09 ABACUS 3.3 ME

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