Nexxis OR K9605023

GUDID 05415334028111

NEXXIS SYSTEM X670 CM US V2

Barco NV

Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system Operating room audiovisual data/device management system
Primary Device ID05415334028111
NIH Device Record Key393fcccf-93a7-4764-88f4-ef3bae5afe69
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexxis OR
Version Model NumberNexxis OR
Catalog NumberK9605023
Company DUNS371618773
Company NameBarco NV
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]
GS105415334028111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Nexxis OR]

05415334002852NEXXIS SYSTEM X670 CM US
05415334002746MNA-420 DEC HDMI
05415334002739MNA-420 DEC HDMI
05415334002722MNA-420 DEC HDMI
05415334002715MNA-420 DEC HDMI
05415334002708MNA-420 DEC HDMI
05415334002692MNA-440 DEC HDMI
05415334002685MNA-440 DEC HDMI
05415334002678MNA-440 DEC HDMI
05415334002661MNA-440 DEC HDMI
05415334002654MNA-440 DEC HDMI
05415334002456MNA-420 DEC HDMI
05415334002395NEXXIS SYSTEM X620 CM
05415334002388NEXXIS SYSTEM X670 CM
05415334002371MNA-440 DEC HDMI
05415334025233Nexxis Management Suite
05415334030220NEXXIS SYSTEM X620 CM V2
05415334030213NEXXIS SYSTEM X670 CM V2
05415334030206MNA-420 ENC HDMI CM XX
05415334030190MNA-420 ENC HDMI CM CN
05415334030183MNA-420 ENC HDMI CM UK
05415334030176MNA-420 ENC HDMI CM EU
05415334030169MNA-420 ENC HDMI CM US
05415334030152MNA-420 ENC HDMI CM XX + CBL 5M
05415334030145MNA-420 ENC HDMI CM CN + CBL 5M
05415334030138MNA-420 ENC HDMI CM UK + CBL 5M
05415334030121MNA-420 ENC HDMI CM EU + CBL 5M
05415334030114MNA-420 ENC HDMI CM US + CBL 5M
05415334025011MNA-240 DEC V2 INC SFP+
05415334028111NEXXIS SYSTEM X670 CM US V2

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