FDA device listing

Hot/Cold Water Bottle

FDA device listing 1337843915 · Ningbo Jenius Medical Tech Co., Ltd.

Key facts

Proprietary names Hot/Cold Water Bottle
Owner/operator Ningbo Jenius Medical Tech Co., Ltd.
Owner/operator number 10044264
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 NINGBO JENIUS POLYMER SCI-TECH CO., LTD
Establishment registrations 3010374920
FEI numbers 3010374920
Establishment operations Foreign Exporter
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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