FDA device listing

KiroGrifols6932 (ED) - KIRO Set

FDA device listing 2027630748 · STERIS Corporation

Key facts

Proprietary names KiroGrifols6932 (ED) - KIRO Set
Owner/operator STERIS Corporation
Owner/operator number 10042227
Product codes LHI
Device names LHI - Set, I.V. Fluid Transfer
Device class Class II
Classification regulations (21 CFR) 880.5440
Review panels General Hospital
Registered establishments Synergy Health Ede BV
Establishment registrations 3009756327
FEI numbers 3002807038
Establishment operations Contract Sterilizer
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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