UDI device identifier

prisMaxPrisMax System 955626

UDI device identifier 00085412639499 · BAXTER HEALTHCARE CORPORATION

Key facts

Primary DI 00085412639499
Brand name prisMaxPrisMax System
Version or model 955626
Catalog number 955626
Company BAXTER HEALTHCARE CORPORATION
DUNS number 005083209
Product code KDI
GMDN term Haemodialysis system, institutional
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jan 31, 2020
Version date Apr 21, 2025
Description The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy

At a glance

  • 10–99 MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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