FDA.reportPublic FDA data

CellaVision® Server Softwaren, Upgrade to next generation

Primary DI
07350040976036
Brand
CellaVision® Server Softwaren, Upgrade to next generation
Company
Cellavision AB
Model
CSS-0000NG
Catalog number
CSS-0000NG
Device description
The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server.
Published
2019-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350040976036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350040976036073500409760367350040976036

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46464601600service@cellavision.se

Regulatory Flags#

DUNS number
508663101
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350040977194CellaVision® Remote Review Single EditionCRRS-SI0099CRRS-SI00992026-05-08
07350040976753HemaPrepXU-10012-012023-01-06
07350040975091CellaVision DC-1XU-103012020-10-22
07350040975107CellaVision DC-1 PPAXU-103022020-10-22
07350040970201CellaVision® DM96XU-10020-01XU-10020-012016-09-20
07350040971277CellaVision® DM1200XU-10127-01XU-10127-012016-09-20
07350040972021Automated Digital Morphology Analyzer DI-60CC286297CC2862972016-09-20
07350040974322CellaVision® DM9600XU-10288-01XU-10288-012016-09-20
07350040972557CellaVision® Body Fluid Application DM1200CBF-120099CBF-1200992016-09-20
07350040972564CellaVision® Body Fluid Application DM96CBF-960099CBF-9600992016-09-20
07350040973707CellaVision® Remote Review Software version 5.0.x, Annual licenseCRRS-005001CRRS-0050012016-09-23
07350040973714CellaVision® Remote Review Software version 5.0.x, Non-expiring licenseCRRS-005099CRRS-0050992016-09-23
07350040973745CellaVision® Advanced RBC Application DM1200CAR-120099CAR-1200992018-03-05
07350040973752CellaVision® Advanced RBC Application DM96CAR-960099CAR-9600992018-03-05
07350040973769CellaVision® Advanced RBC Application DM9600CAR-970099CAR-9700992018-03-05
07350040973776CellaVision® Body Fluid Application DM9600CBF-970099CBF-9700992016-09-20
07350040974506CellaVision® Remote Review Software version 6.0.x, Annual licenseCRRS-006001CRRS-0060012016-09-23
07350040974513CellaVision® Remote Review Software version. 6.0.x, Non-expiring licenseCRRS-006099CRRS-0060992016-09-23
07350040974537CellaVision® Remote Review Software, Enterprise Edition, version 6.0.xCRRS-EN6099CRRS-EN60992016-09-23
07350040974544CellaVision® Remote Review Software, Enterprise upgrade from Group Ed.CRRS-ENGR99CRRS-GRGR992019-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28