NAVOYCDS

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

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 decision 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, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Regulatory Flags#

DUNS number
353333039
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 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