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Prismax 955724

by Vantive Health GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07332414126018 UDI-DI Date21 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2438-2025 FDA Class II initiated 28 Jul 2025

    Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure

    • Ongoing Z-2439-2025 FDA Class II initiated 28 Jul 2025

    Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Prismax
Generic Name
Haemodialysis system, institutional
Model / Ref / Catalog
955724
Primary DI / UDI-DI
07332414126018
510(k) Number
FDA Product Code
KDI
GMDN Term
Haemodialysis system, institutional
Device Class
Class II
Regulation Number
876.5860
GUDID distribution status
In Commercial Distribution

Other devices from Vantive Health GmbH

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No