Nexxis K9605013

GUDID 05415334002081

NEXXIS SYSTEM ST KIT 2

Barco NV

Operating room audiovisual data/device management system

• Primary Device ID: 05415334002081
• NIH Device Record Key: bb769dc1-4ac1-4aee-9545-b54950683d8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexxis
• Version Model Number: NEXXIS SYSTEM ST KIT 2
• Catalog Number: K9605013
• Company DUNS: 371618773
• Company Name: Barco NV
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com
• Phone: +1(866)302-7939
• Email: service.medical.usa@barco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334002081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122167

FDA Product Code

• DXJ: DISPLAY, CATHODE-RAY TUBE, MEDICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-20
• Device Publish Date: 2017-07-14

On-Brand Devices [Nexxis]

• 05415334002562: MNA-420 ENC HDMI XX (no mains power cable)
• 05415334002555: MNA-420 ENC HDMI EU
• 05415334002548: MNA-420 ENC HDMI UK
• 05415334002531: MNA-420 ENC HDMI CN
• 05415334002524: MNA-420 ENC HDMI US
• 05415334002517: MNA-440 ENC HDMI XX (no mains power cable)
• 05415334002500: MNA-440 ENC HDMI EU
• 05415334002494: MNA-440 ENC HDMI UK
• 05415334002487: MNA-440 ENC HDMI CN
• 05415334002470: MNA-440 ENC HDMI US
• 05415334002364: MNA-420 ENC HDMI
• 05415334002180: MNA-440 ENC HDMI
• 05415334002081: NEXXIS SYSTEM ST KIT 2
• 05415334002074: 4K ENC BUNDLE OL
• 05415334002067: NEXXIS SYSTEM ST KIT 1
• 05415334002036: MNA-240 DEC V2 ST
• 05415334001787: DEC DVI AUDIO ST
• 05415334001770: ENC DVI AUDIO ST
• 05415334001701: MNA-240 ENC DP OL
• 05415334001664: MNA-240 ENC DP KS
• 05415334001657: MNA-240 ENC DP MQ
• 05415334001640: MNA-240 DEC V2 OL
• 05415334001633: MNA-240 DEC V2 MQ
• 05415334001626: MNA-240 DEC V2 AT
• 05415334001619: MNA-240 DEC V2
• 05415334001084: MNA-240 DEC AT
• 05415334001077: MNA-110 ENC HDSDI AT
• 05415334001060: MNA-110 ENC DP AT
• 05415334001053: MNA-110 ENC HDSDI OL
• 05415334001046: MNA-110 ENC DP OL
• 05415334001039: MNA-110 ENC DVI OL
• 05415334001022: MNA-120 ENC HDSDI AUDIO OL
• 05415334001015: MNA-120 ENC DP AUDIO OL
• 05415334001008: MNA-120 ENC DVI AUDIO OL
• 05415334000995: MNA-120 ENC ANA AUDIO OL
• 05415334000988: MNA-120 DEC DVI AUDIO OL
• 05415334000971: MNA-110 ENC DVI TMS
• 05415334000964: MNA-110 ENC DVI TMS+CBL
• 05415334000957: MNA-120 ENC DVI AUDIO TMS+CBL
• 05415334000940: MNA-120 ENC DVI AUDIO TMS
• 05415334000933: MNA-120 DEC DVI AUDIO TMS
• 05415334000926: MNA-120 ENC ANA AUDIO TMS+CBL
• 05415334000919: MNA-120 ENC ANA AUDIO TMS
• 05415334000902: MNA-110 ENC HDSDI MQ
• 05415334000896: MNA-110 ENC DP MQ
• 05415334000889: MNA-110 ENC DVI MQ
• 05415334000872: MNA-120 ENC HDSDI AUDIO MQ
• 05415334000865: MNA-120 ENC DP AUDIO MQ
• 05415334000858: MNA-120 ENC DVI AUDIO MQ
• 05415334000841: MNA-120 ENC ANA AUDIO MQ