FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995161392
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
M-Series Suspension
Catalog number
LM99APIT
Device description
The Single Arm All Power with ConnectPoint, Tandem and Mounting Plate is exclusively used with the HarmonyAIR M-Series Suspension Systems.
Published
2020-06-17
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
00724995161392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995161392007249951613927249951613920724995161392

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
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
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
00724995185961HarmonyAIRA-Series Suspension SystemLAS52NCND2020-05-28

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
00724995246150HarmonyAIRSTERIS 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