FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995171049
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
E-Series Suspension System
Catalog number
LES000006
Device description
The HarmonyAIR E-Series Spindle Single Light Head is a ceiling supported suspension system.
Published
2020-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTABLE, OPERATING-ROOM, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995171049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995171049007249951710497249951710490724995171049

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

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
00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
00724995222031NATable ExtensionBF002612026-02-13
00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995232016NASTERIS CORPORATIONFQO2026-05-26
00724995232023NASTERIS CORPORATIONFQO2026-05-26
00724995232054NASTERIS CORPORATIONFQO2026-05-26
00724995232061NASTERIS CORPORATIONFQO2026-05-26
00724995232078NASTERIS CORPORATIONFQO2026-05-26
10841736124410Skytron 200 x 400 VESA Adapter PlateSKYTRON LLCFQO2026-03-19
04061591001032MultibarOndal Medical Systems GmbHFQO2026-02-02
00190376678665ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678689ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678764ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678771ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678795ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678801ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678818ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678825ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678832ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
10841736124298Skytron LLCSKYTRON LLCFQO2025-12-09
10841736124861SkytronSKYTRON LLCFQO2025-12-03
10841736125226SkytronSKYTRON LLCFQO2025-12-03
06948350528826MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528833MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528864MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
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06948350528895MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528901MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528918MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528925MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528932MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528949MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22