FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995161378
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
M-Series Suspension
Catalog number
LM0099API
Device description
The All Power Add-On Arm with ConnectPoint M -Series is used with the HarmonyAIR M-Series Suspension System.
Published
2020-05-15
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
00724995161378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995161378007249951613787249951613780724995161378

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
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
00724995239909V. MuellerDP11DP112026-10-15
00724995239916V. MuellerDP12DP122026-10-15
00724995239923V. MuellerDP13DP132026-10-15
00724995239930V. MuellerDP14DP142026-10-15
00724995239947V. MuellerDP15DP152026-10-15
00724995239985V. MuellerED112ED1122026-10-15
00724995239992V. MuellerED15ED152026-10-15
00724995240004V. MuellerED16ED162026-10-15
00724995240011V. MuellerED17ED172026-10-15
00724995240028V. MuellerED19ED192026-10-15
00724995240660V. MuellerPP11PP112026-10-15
00724995240677V. MuellerPP12PP122026-10-15
00724995240684V. MuellerPP125PP1252026-10-15
00724995240691V. MuellerPP13PP132026-10-15
00724995240707V. MuellerPP14PP142026-10-15
00724995241025V. MuellerR1051R10512026-10-15
00724995241049V. MuellerR1065R10652026-10-15
00724995241056V. MuellerR1067R10672026-10-15
00724995241063V. MuellerR1069R10692026-10-15
00724995241070V. MuellerR1072R10722026-10-15

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