FDA device listing

THERMOMETER, CLINICAL COLOR CHANGE

FDA device listing 1923340622 · SunMed Group Holdings, LLC dba AirLife

Key facts

Proprietary names THERMOMETER, CLINICAL COLOR CHANGE
Owner/operator SunMed Group Holdings, LLC dba AirLife
Owner/operator number 10044795
Product codes FQZ
Device names FQZ - Thermometer, Clinical Color Change
Device class Class I
Classification regulations (21 CFR) 880.2900
Review panels General Hospital
Registered establishments PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V., SunMed Group Holdings, LLC
Establishment registrations 1314417, 8030673
FEI numbers 1314417, 3004213967
Establishment operations Complaint File Establishment, Specification Developer, Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 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

Browse all FDA device listings