FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995201227
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
A-Series Camera
Catalog number
LAH00264K
Device description
The STERIS A-Series 4K Camera Module is used with the HarmonyAIR A-Series Lighting System.
Published
2021-07-28
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
KQMCAMERA, SURGICAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995201227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995201227007249952012277249952012270724995201227

GMDN Terms#

Term, Definition table
TermDefinition
Surgical video cameraAn electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2026-05-15
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2025-02-28
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.KQM2024-06-11
06932503563703eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2024-02-09
06932503563765eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2024-02-09
14714127861392AESCULAPAesculap AGKQM2023-11-05