FDA device listing

CMI PUMP

FDA device listing 1973693603 · UTAH MEDICAL PRODUCTS, INC.

Key facts

Proprietary names CMI PUMP
Owner/operator UTAH MEDICAL PRODUCTS, INC.
Owner/operator number 1718873
Premarket submissions K895446
Product codes HDB
Device names HDB - Extractor, Vacuum, Fetal
Device class Class II
Classification regulations (21 CFR) 884.4340
Review panels Obstetrics/Gynecology
Registered establishments UTAH MEDICAL PRODUCTS, INC.
Establishment registrations 1718873
FEI numbers 1718873
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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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