FDA device listing

System, Gastrointestinal Motility (Electrical)

FDA device listing 1059381553 · Nutra-Med Packaging LLC.

Key facts

Owner/operator Nutra-Med Packaging LLC.
Owner/operator number 10081914
Premarket submissions K881609
Product codes FFX
Device names FFX - System, Gastrointestinal Motility (Electrical)
Device class Class II
Classification regulations (21 CFR) 876.1725
Review panels Gastroenterology & Urology
Registered establishments NUTRA-MED PACKAGING LLC.
Establishment registrations 3002821211
FEI numbers 3002821211
Establishment operations Repackager/Relabeler
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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