FDA device listing

CADINAL HEALTH,Predictive Temperature Module,SureTemp Box Set

FDA device listing 1042599594 · KIMBALL SOLUTIONS GROUP, LLC

Key facts

Proprietary names CADINAL HEALTH,Predictive Temperature Module,SureTemp Box Set
Owner/operator KIMBALL SOLUTIONS GROUP, LLC
Owner/operator number 9071700
Product codes SDV
Device names SDV - Clinical Electronic Thermometer
Device class Class II
Classification regulations (21 CFR) 880.2910
Review panels General Hospital
Registered establishments Kimball Electronics Poland Sp.z o.o, Kimball Electronics - Thailand LTD
Establishment registrations 3003660459, 3008058135
FEI numbers 3003660459, 3008058135
Establishment operations 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

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