FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995186623
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
A-Series Lighting System
Catalog number
LAH01INNDT
Device description
The A-Series High Density Dual Light 43-inch Light, 35.5-inch Light, No Drop Tube, Tandem is used with the HarmonyAIR A-Series Lighting System.
Published
2020-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSYLight, surgical, ceiling mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995186623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995186623007249951866237249951866230724995186623

GMDN Terms#

Term, Definition table
TermDefinition
Operating light systemAn assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B510SL700700LED1ADVANCED SURGICAL LAMP ADVANCED INSTRUMENTATIONS, INC.FSY2026-03-24
20192253051985DevonCardinal Health 200, LLCFSY2026-03-11
00850053798016APEX LEDBurton Medical, LLCFSY2026-02-19
00684706009682iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009699iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009705iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009712iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009729iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009736iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009743iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009750iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009767iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009774iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009781iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009798iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009811iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009828iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00724995243593ALYONSTERIS CORPORATIONFSY2026-01-05
00684706009675iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-25
00684706009644iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009651iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009668iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009330iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009347iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009361iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009378iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009385iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009392iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009408iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009415iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15