FDA device listing

NAMIC Perceptor DT Disposable Transducer,NAMIC Perceptor DT Monitoring Kit,NAMIC Perceptor DT Pressuring Monitoring…

FDA device listing 1868136624 · Medline Industries, LP

Key facts

Proprietary names NAMIC Perceptor DT Disposable Transducer,NAMIC Perceptor DT Monitoring Kit,NAMIC Perceptor DT Pressuring Monitoring Kit,NAMIC Perceptor DT Standard Pole Mount Kit
Owner/operator Medline Industries, LP
Owner/operator number 1417592
Premarket submissions K910764
Product codes DRS
Device names DRS - Transducer, Blood-Pressure, Extravascular
Device class Class II
Classification regulations (21 CFR) 870.2850
Review panels Cardiovascular
Registered establishments MEDLINE INDUSTRIES, LP (Northpoint Services), Medline Industries (NAMIC Division) - Glen Falls
Establishment registrations 1422634, 3015910259
FEI numbers 1000514656, 3015910259
Establishment operations Contract Sterilizer, Manufacturer
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

Browse all FDA device listings