FDA.report

Clinical review 1MP

Primary DI
05415334000414
Brand
Clinical review 1MP
Company
Barco NV
Model
MDRC-1119 HB
Published
2016-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LMDSystem, digital image communications, radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05415334000414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05415334000414054153340004145415334000414

GMDN Terms

TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
371618773
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05415334050020BarcoMDSC-8532 K93530182025-12-22
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334054967Nio 5.8MP ColorMDNC-6121K9300360C1X2025-08-11
05415334054974Nio 5.8MP ColorMDNC-6121K9300361C1X2025-08-11
05415334054981Nio 5.8MP GrayMDNG-6221K9300370C1X2025-08-11
05415334054998Nio 5.8MP GrayMDNG-6221K9300372C1X2025-08-11
05415334058415BarcoIWT 2.4.xK93082542025-08-05
05415334051133SterisVividImage 32 4K MiniLEDRLM324KMINI2025-06-05
05415334053458BarcoMNA-4406003014792025-06-04
05415334053472BarcoMNA-1206003014812025-06-04
05415334053663BarcoMNA-2406003014822025-06-04
05415334053670BarcoMNA-4206003060272025-06-04
05415334049895Coronis Fusion 4MPMDCC-4430K9301626B2X2025-04-16
05415334049901Coronis Fusion 4MPMDCC-4430K9301628B2X2025-04-16
05415334049925Coronis Fusion 6MPMDCC-6530K9301636B2X2025-04-16
05415334049932Coronis Fusion 6MPMDCC-6530K9301638B2X2025-04-16
05415334053717BarcoMDRC-2422K9356038A1X2025-04-14
05415334053724BarcoMDRC-2422K9356039A1X2025-04-14

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04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01
00612479273597McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277359McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277366McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00850061871268IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871275IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871282IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850025268332Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-05-16
07649988969867OptiVu StreamerINCREMED AGLMD2025-04-24
00850054590121interWORKSAvreo IncLMD2025-04-22
00300021451554Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
00300021458553Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
05415334053717BarcoBarco NVLMD2025-04-14
05415334053724BarcoBarco NVLMD2025-04-14
05415334053731BarcoBarco NVLMD2025-04-14
05415334054059BarcoBarco NVLMD2025-04-14