FDA.report

HarmonyAIR

Primary DI
00724995187682
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
A-Series Lighting System
Catalog number
LAH11IN01T
Device description
The A-Series High Density Single Light, Dual Monitor Mount 51-inch Dual Monitor Mount, 43-inch Light, 13-inch Drop Tube, Tandem is used with the HarmonyAIR A-Series Lighting System.
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSYLight, surgical, ceiling mounted

Product Code Classifications

CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00724995187682PrimaryGS10

GMDN Terms

TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags

DUNS number
036985604
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00724995222031NATable ExtensionBF002612026-02-13
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00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13
00724995222086NATable ExtensionBF002662026-02-13
00724995222093NATable ExtensionBF002672026-02-13
00724995222109NATable ExtensionBF002682026-02-13
00724995244972NATAB800KTLBF7942026-02-13
00724995246891NATable Pad S00XWBF7682026-02-13
00724995246907NATable Pad S20CV3BF7692026-02-13

Other Devices Sharing Product Codes

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
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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
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