FDA device listing

HANG&GO HT BASIC,PERFORMER HT

FDA device listing 1748665777 · RAND S.p.A.

Key facts

Proprietary names HANG&GO HT BASIC,PERFORMER HT
Owner/operator RAND S.p.A.
Owner/operator number 9063301
Premarket submissions K120026
Product codes LGZ
Device names LGZ - Warmer, Thermal, Infusion Fluid
Device class Class II
Classification regulations (21 CFR) 880.5725
Review panels General Hospital
Registered establishments RAND S.p.A.
Establishment registrations 3003793891
FEI numbers 3003793891
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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