FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995153328
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
Monitor Carrier
Catalog number
HCEL100002
Device description
The HarmonyAIR Monitor Carrier Philips Compatibility, V 8.2, Extended Long, 1000mm Arm is a monitor mounting system designed for complex procedural environments.
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00724995153328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995153328007249951533287249951533280724995153328

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
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995234232V. MuellerCD14BCD14B2026-08-26
00724995234249V. MuellerCD14BBLACKCD14BBLACK2026-08-26
00724995234256V. MuellerCD14BBLUECD14BBLUE2026-08-26
00724995234263V. MuellerCD14BGOLDCD14BGOLD2026-08-26
00724995234270V. MuellerCD14BGREENCD14BGREEN2026-08-26
00724995234287V. MuellerCD14BPURPLECD14BPURPLE2026-08-26
00724995234294V. MuellerCD14BREDCD14BRED2026-08-26
00724995234300V. MuellerCD14CCD14C2026-08-26
00724995234317V. MuellerCD14CBLACKCD14CBLACK2026-08-26
00724995234324V. MuellerCD14CBLUECD14CBLUE2026-08-26
00724995234331V. MuellerCD14CGOLDCD14CGOLD2026-08-26
00724995234348V. MuellerCD14CGREENCD14CGREEN2026-08-26
00724995234355V. MuellerCD14CPURPLECD14CPURPLE2026-08-26
00724995234362V. MuellerCD14CREDCD14CRED2026-08-26
00724995234379V. MuellerCD15BCD15B2026-08-26
00724995234386V. MuellerCD15BBLACKCD15BBLACK2026-08-26
00724995234393V. MuellerCD15BBLUECD15BBLUE2026-08-26
00724995234409V. MuellerCD15BGOLDCD15BGOLD2026-08-26
00724995234416V. MuellerCD15BGREENCD15BGREEN2026-08-26
00724995234423V. MuellerCD15BPURPLECD15BPURPLE2026-08-26

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
00724995232016NASTERIS CORPORATIONFQO2026-05-26
00724995232023NASTERIS CORPORATIONFQO2026-05-26
00724995232054NASTERIS CORPORATIONFQO2026-05-26
00724995232061NASTERIS CORPORATIONFQO2026-05-26
00724995232078NASTERIS CORPORATIONFQO2026-05-26
04260217220899WB FA24Amtrion GmbHFQO2026-04-08
00724995362317HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362324HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362331HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362348HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362355HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362362HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362379HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362386HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362393HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362409HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362416HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362423HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362430HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362447HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362454HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
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
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678689ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23