Deterioration Index Version 2

Primary DI
00850053416019
Brand
Deterioration Index Version 2
Company
EPIC SYSTEMS CORPORATION
Model
2
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNLMedium-Term Adjunctive Predictive Cardiovascular IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260008000Deterioration Index Version 2Epic Systems Corporation2026-09-18QNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053416019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053416019008500534160198500534160190850053416019

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
108299124
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053416002Blood Product Administration Module42025-02-03
00860475000383Automated Wound Measurements12025-02-03
00860475000345Blood Product Administration Module22023-06-19
00860475000314Blood Product Administration Module32020-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403523437HemoSphere AltaBecton, Dickinson And CompanyQNL2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyQNL2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyQNL2026-08-06
00690103219616ForeSight IQEdwards Lifesciences LLCQNL2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCQNL2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCQNL2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
07290018852002CLEWICUCLEW MEDICAL LTDQNL2024-12-09
03770025266015SignalHFImplicity Inc.QNL2024-04-16
B823AHIV200AHI SystemFifth Eye, Inc.QNL2022-02-12