FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995246136
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
HarmonyAIR Monitor Carrier Multibar
Catalog number
HCEL100001MB1
Device description
HarmonyAIR Monitor Carrier Large Format Standard, 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
00724995246136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995246136007249952461367249952461360724995246136

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
00724995248444Snowden-Pencer886118V886118V2026-10-27
00724995248451Snowden-Pencer886122V886122V2026-10-27
00724995248468Snowden-Pencer886127V886127V2026-10-27
10885403035562V. MuellerCH8680CH86802020-04-15
10885403035579V. MuellerCH8680-001CH86800012020-04-15
10885403035586V. MuellerCH8681CH86812020-04-15
10885403022470V. MuellerRH600RH6002018-09-14
10885403092084V. MuellerOP0907-601OP09076012018-09-05
10885403092091V. MuellerOP0907-602OP09076022018-09-05
10885403099120V. MuellerOP5000OP50002018-09-07
10885403099137V. MuellerOP5005OP50052018-09-07
10885403099144V. MuellerOP5500OP55002018-09-07
10885403099182V. MuellerOP5505OP55052018-09-07
10885403099199V. MuellerOP5510OP55102018-09-07
10885403099205V. MuellerOP5520OP55202018-09-07
10885403099625V. MuellerOP5666OP56662019-01-02
10885403099717V. MuellerOP5700OP57002019-01-02
10885403099779V. MuellerOP5760OP57602019-01-02
10885403099786V. MuellerOP5761OP57612019-01-02
10885403104909V. MuellerOS4610OS46102018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995362980STERISSTERIS CORPORATIONFQO2026-10-08
00724995362997STERISSTERIS CORPORATIONFQO2026-10-08
00724995363000STERISSTERIS CORPORATIONFQO2026-10-08
00724995363024STERISSTERIS CORPORATIONFQO2026-10-08
00724995363031STERISSTERIS CORPORATIONFQO2026-10-08
00724995363048STERISSTERIS CORPORATIONFQO2026-10-08
00724995363116STERISSTERIS CORPORATIONFQO2026-10-08
00724995363123STERISSTERIS CORPORATIONFQO2026-10-08
00724995363147STERISSTERIS CORPORATIONFQO2026-10-08
00724995363154STERISSTERIS CORPORATIONFQO2026-10-08
00724995363161STERISSTERIS CORPORATIONFQO2026-10-08
00724995363291NASTERIS CORPORATIONFQO2026-10-08
00724995363307NASTERIS CORPORATIONFQO2026-10-08
00724995363369NASTERIS CORPORATIONFQO2026-10-08
00724995363376NASTERIS CORPORATIONFQO2026-10-08
00724995363383NASTERIS CORPORATIONFQO2026-10-08
00724995363390NASTERIS CORPORATIONFQO2026-10-08
00724995363413NASTERIS CORPORATIONFQO2026-10-08
00724995363901NASTERIS CORPORATIONFQO2026-10-08
00724995363918NASTERIS CORPORATIONFQO2026-10-08
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
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