PCWP Analysis Software

Primary DI
00860011800620
Brand
PCWP Analysis Software
Company
CARDIOSENSE, INC.
Model
PCWP Analysis Software
Device description
AI/ML based algorithm to estimate PCWP
Published
2026-10-14
Public version status
New
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
SIFSoftware Device System For Estimation Of Cardiac Pressures

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SIFSoftware Device System For Estimation Of Cardiac Pressures

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250057000PCWP Analysis SoftwareCardiosense, Inc.2026-05-22SIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011800620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011800620008600118006208600118006200860011800620

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary physiological parameter analysis software, professional-onlyA software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.

Regulatory Flags#

DUNS number
119080581
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
00860011800613CardioTagCardioTag2026-10-14