FDA device listing

CS-200895 DSU-H Ultrafilter Installation Kit,CS-200900 DSU-H Ultrafilter Replacement Kit

FDA device listing 2055810546 · CS MEDICAL LLC

Key facts

Proprietary names CS-200895 DSU-H Ultrafilter Installation Kit,CS-200900 DSU-H Ultrafilter Replacement Kit
Owner/operator CS MEDICAL LLC
Owner/operator number 9086031
Premarket submissions K141731
Product codes NHV
Device names NHV - System, Water Purification, General Medical Use
Device class Class II
Classification regulations (21 CFR) 876.5665
Review panels Gastroenterology & Urology
Registered establishments CS MEDICAL LLC
Establishment registrations 3005698329
FEI numbers 3005698329
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

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

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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