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HarmonyAIR

FDA UDI

Class II (US FDA UDI)

by Steris Corporation

Identity

Trade Name
HarmonyAIR FDA UDI
Generic Name
Operating room light FDA UDI
Device Name
The A-Series High Density Single Light, Dual Monitor Mount 51-inch Dual Monitor Mount, 35.5-inch Light, 20-inch Drop Tube, No Controller is used with the HarmonyAIR A-Series Lighting System. FDA UDI
Model / Reference
A-Series Lighting System FDA UDI
Description
The A-Series High Density Single Light, Dual Monitor Mount 51-inch Dual Monitor Mount, 35.5-inch Light, 20-inch Drop Tube, No Controller is used with the HarmonyAIR A-Series Lighting System. FDA UDI

Identifiers

Catalog Number
LAH13NC02 FDA UDI
Primary DI / UDI-DI
00724995187781 FDA UDI
FDA Product Code
FSY FDA UDI
GMDN Term
Operating room light FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating room light systemOperating room lightMedical monitor/light mount

HarmonyAIR by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical monitor/light mount.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steris Corporation

Sources (1)

  • FDA UDI 24856d6a-90d5-42e5-8345-e9b6fbfa94a4 35 fields · synced Jun 8, 2026