FDA.reportPublic FDA data

Nexxis OR

Primary DI
05415334062412
Brand
Nexxis OR
Company
Barco NV
Model
Nexxis system
Catalog number
K9610426
Device description
NEXXIS ULTIMAX KIT2
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXJDisplay, Cathode-Ray Tube, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173381000Nexxis ORBarco N.V.2018-02-22DXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415334062412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334062412054153340624125415334062412

GMDN Terms#

Term, Definition table
TermDefinition
Operating room audiovisual data/device management systemA mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices.

Contacts#

Phone, Email table
PhoneEmail
+1 866-302-7939service.medical.usa@barco.com

Regulatory Flags#

DUNS number
371618773
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334057265Nio Color 8MPMDNC-8132K9300830B2X2026-05-07
05415334036277Nexxis ORNexxis systemK96104202021-06-28
05415334057258Eonis 32”MDRC-8132K9350830B2X2026-04-13
05415334050020BarcoMDSC-8532 K93530182025-12-22
05415334000148Nio 2MPE 2620 S2016-06-30
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334000155Barco Mammo TomosynthesisMDMG-52212016-06-30
05415334000162Coronis 3MP LEDMDCG-32212016-06-30
05415334000247Coronis Fusion 4MP LEDMDCC-4330K9301625A2016-06-30
05415334000261Coronis Fusion 6MP LEDMDCC-6430K9301635A2016-06-30
05415334000339Nio 3MP LEDMDNG-3220K9301860A2016-06-30
05415334000353Nio 3MP LEDMDNG-3220K9301862A2016-06-30
05415334000360Nio 3MP LEDMDNG-3220K9301863A2016-06-30
05415334000513Coronis Fusion 6MP LEDMDCC-6430K9301635B2016-08-30
05415334001077NexxisMNA-110K9303177A2016-06-30
05415334054967Nio 5.8MP ColorMDNC-6121K9300360C1X2025-08-11
05415334054974Nio 5.8MP ColorMDNC-6121K9300361C1X2025-08-11
05415334054981Nio 5.8MP GrayMDNG-6221K9300370C1X2025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251303302278CuratOREIZO GmbHDXJ2026-03-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXJ2026-02-11
05415334053458BarcoBarco NVDXJ2025-06-04
05415334053472BarcoBarco NVDXJ2025-06-04
05415334053663BarcoBarco NVDXJ2025-06-04
05415334053670BarcoBarco NVDXJ2025-06-04
10889483575710Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575734Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575772Vital Signs™AirLife Finland OyDXJ2025-03-31
05415334050815Nexxis ORBarco NVDXJ2024-02-22
05415334050822Nexxis ORBarco NVDXJ2024-02-22
05415334050839Nexxis ORBarco NVDXJ2024-02-22
10193489385625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
40193489385626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
05415334037625Nexxis ORBarco NVDXJ2023-05-25
05415334037632Nexxis ORBarco NVDXJ2023-05-25
05415334037687Nexxis ORBarco NVDXJ2023-05-25
05415334042346Nexxis ORBarco NVDXJ2023-05-25
06970438060003BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
06970438060065BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
05415334039124Nexxis ORBarco NVDXJ2022-07-11
05415334039131Nexxis ORBarco NVDXJ2022-07-11
10884450568658High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-31
20884450387669High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-15
10884450569334Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-03-05
20884450387676High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-04
20884450569720Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-03-04
10884450569297Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-02-28
20884450569317Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-02-28
04033817903161ESSENZLivaNova Deutschland GmbHDXJ2022-02-24