FDA device listing

BASIN, EMESIS

FDA device listing 1941153269 · Garware Fulflex India Private Ltd (Formerly Garware Bestretc

Key facts

Proprietary names BASIN, EMESIS
Owner/operator Garware Fulflex India Private Ltd (Formerly Garware Bestretc
Owner/operator number 9069342
Product codes FNY
Device names FNY - Basin, Emesis
Device class Class I
Classification regulations (21 CFR) 880.6730
Review panels General Hospital
Registered establishments Garware Fulflex Texas Inc.
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • None Registered establishments listing this device
  • None listed 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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