Sepsis ImmunoScore

GUDID 00860013516208

Clinical management support software IVD

Primary Device ID	00860013516208
NIH Device Record Key	bc34ae57-57e1-4334-943c-a9023069bcbf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sepsis ImmunoScore
Version Model Number	1.5.0
Company DUNS	079414131
Company Name	Prenosis, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860013516208 [Primary]

SAK	Software Device To Aid In The Prediction Or Diagnosis Of Sepsis

Steralize Prior To Use	false
Device Is Sterile	false

Mark Image Registration \| Serial	Company Trademark Application Date
SEPSIS IMMUNOSCORE 98511201 not registered Live/Pending	Prenosis, Inc. 2024-04-21