NAVOYCDS

Primary DI
07350140270027
Brand
NAVOYCDS
Company
AlgoDx AB
Model
1.0
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PLBMultivariate Vital Signs Index

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLBMultivariate Vital Signs IndexCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240558000NAVOYCDSAlgodx AB2024-07-22PLB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350140270027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350140270027073501402700277350140270027

GMDN Terms#

Term, Definition table
TermDefinition
Clinical management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.

Regulatory Flags#

DUNS number
353333039
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863061000316T3 PLATFORM SOFTWAREETIOMETRY INC.PLB2026-03-17
00863061000323ETIOMETRY PLATFORMETIOMETRY INC.PLB2026-03-17
00850071330038prolaio Personalized Physiology Analytics Engine Software (PPA)Prolaio, Inc.PLB2025-06-13
08809957910002SpassageQSpass Co.,Ltd.PLB2023-06-27
08885018690021Biovitals Analytics EngineBIOFOURMIS SINGAPORE PTE. LTD.PLB2022-10-28
00860004366263physIQ Personalized Physiology Analytics EnginePHYSIQ, INCPLB2022-01-10
00863061000309T3 Risk Analytics PlatformETIOMETRY INC.PLB2016-09-09