Sepsis ImmunoScore

Primary DI
00860013516208
Brand
Sepsis ImmunoScore
Company
Prenosis, Inc.
Model
1.6.0
Published
2025-05-20
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
SAKSoftware Device To Aid In The Prediction Or Diagnosis Of Sepsis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAKSoftware Device To Aid In The Prediction Or Diagnosis Of SepsisGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230036000Sepsis ImmunoScorePrenosis, Inc.2024-04-02SAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013516208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013516208008600135162088600135162080860013516208

GMDN Terms#

Term, Definition table
TermDefinition
Clinical management support software IVDAn in vitro diagnostic application software program intended to facilitate clinical management decisions by receiving structured 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, pedigree diagrams, reminders, post-therapy prognosis/risk score, suggested pharmaceutical dosage) to a healthcare professional responsible for patient care. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application. It is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(312) 235-3580madison.green@prenosis.com

Regulatory Flags#

DUNS number
079414131
Device count
1
Lot or batch
true