UDI device identifier

PRISMAFLEX SET M150

UDI device identifier 07332414090005 · GAMBRO INDUSTRIES

Key facts

Primary DI 07332414090005
Brand name PRISMAFLEX SET
Version or model M150
Catalog number 109990
Company GAMBRO INDUSTRIES
DUNS number 393020474
Product code KDI
GMDN term Haemofilter
Premarket submission K080519
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Oct 5, 2015
Version date Aug 10, 2023
Description The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal…

At a glance

  • 10–99 MAUDE reports citing this UDI
  • Yes 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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