FDA device listing

Thermalon

FDA device listing 1091356732 · The Hilsinger Company Parent, LLC

Key facts

Proprietary names Thermalon
Owner/operator The Hilsinger Company Parent, LLC
Owner/operator number 1218954
Product codes FPF
Device names FPF - Bottle, Hot/Cold Water
Device class Class I
Classification regulations (21 CFR) 880.6085
Review panels General Hospital
Registered establishments BRUDER HEALTHCARE COMPANY
Establishment registrations 1039131
FEI numbers 1039131
Establishment operations Complaint File Establishment, Specification Developer
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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