FDA.reportPublic FDA data

Nexxis OR

Primary DI
05415334034839
Brand
Nexxis OR
Company
Barco NV
Model
MNA-420
Catalog number
K9350202F
Device description
MNA-420 DEC HDMI V2 INC SFP+ EU
Published
2021-04-22
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
05415334034839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334034839054153340348395415334034839

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334058460BarcoNMS 22026-11-03
05415334059122BarcoMNA-420 ENC ANAK93033402026-11-03
05415334062573BarcoMNA-420 ENC ANAK9303340B2026-11-03
05415334062993BarcoMNA-420 ENC ANAK9303340X2026-11-03
05415334059405BarcoMNA-410 WPMK93516812026-10-12
05415334050037BarcoMDSC-8532K93530172026-10-01
05415334050068BarcoMDSC-8532K93530152026-10-01
05415334059139BarcoMCC-300K93513022026-09-21
05415334059924BarcoMCC-300K93513012026-09-21
05415334059931BarcoMCC-300K93513002026-09-21
05415334001671BarcoMDSC-8255K9307933022020-07-29
05415334001879BarcoMDSC-8255K9307930022020-07-29
05415334001886BarcoMDRC-2222K93079432020-07-29
05415334001961BarcoMDSC-8255K93079322020-07-29
05415334001978BarcoMDSC-2324K93079482020-07-29
05415334002098BarcoMDSC-2326K93079512020-07-29
05415334002104BarcoMDSC-2326K93079522020-07-29
05415334002227BarcoMDSC-2326K93079542020-07-29
05415334002913BarcoMDSC-2326K9307951B2020-07-29
05415334002920BarcoMDSC-2326K9307954B2020-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334058460BarcoBarco NVDXJ2026-11-03
05415334059122BarcoBarco NVDXJ2026-11-03
05415334062573BarcoBarco NVDXJ2026-11-03
05415334062993BarcoBarco NVDXJ2026-11-03
05415334062412Nexxis ORBarco NVDXJ2026-04-28
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