FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995246150
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
HarmonyAIR Monitor Carrier Multibar
Catalog number
HCEL100004MB1
Device description
HarmonyAIR Monitor Carrier 4 Front Facing Monitor, Extension Long, 1000MM Arm, Multibar 1
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00724995246150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995246150007249952461507249952461500724995246150

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.

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
10885403053924V. MuellerLA8506-45LA8506452016-09-24
00724995165307NAX-Ray Table TopBF6512021-04-02
10724995023833VERIFYDual SpeciesS3062016-09-09
10724995032798DARTNB113NB1132016-09-09
10724995154735VERIFY SIXCESSPCC072PCC0722019-04-19
10724995154742VERIFY SIXCESSPCC073PCC0732019-04-19
00724995000783Revital-Ox Resert4455N94455N92016-09-07
00724995095017Revital-Ox Resert4455AW4455AW2016-09-07
00724995153779AmscoWarming CabinetDJ060144123132020-06-11
00724995153816AmscoWarming CabinetDJ060144331112020-06-11
00724995161392HarmonyAIRM-Series SuspensionLM99APIT2020-06-17
00724995170493HarmonyAIRG-Series SuspensionLK00162020-05-19
00724995185886HarmonyAIRA-Series Suspension SystemLAS30NC012020-05-28
00724995185893HarmonyAIRA-Series Suspension SystemLAS30NC022020-05-28
00724995185909HarmonyAIRA-Series Suspension SystemLAS30NCND2020-05-28
00724995185916HarmonyAIRA-Series Suspension SystemLAS30NC01T2020-05-28
00724995185923HarmonyAIRA-Series Suspension SystemLAS30NC02T2020-05-28
00724995185930HarmonyAIRA-Series Suspension SystemLAS30NCNDT2020-05-28
00724995185947HarmonyAIRA-Series Suspension SystemLAS52NC012020-05-28
00724995185954HarmonyAIRA-Series Suspension SystemLAS52NC022020-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
00724995362317HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362324HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362331HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362348HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678740ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678757ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678788ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678887ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376729473ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00724995246136HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246143HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246167HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246174HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246181HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246198HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246204HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246211HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246228HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246235HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246242HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246259HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246266HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246273HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246280HarmonyAIRSTERIS CORPORATIONFQO2025-11-19
00724995246297HarmonyAIRSTERIS CORPORATIONFQO2025-11-19