CaRi-Heart

Primary DI
05060737370017
Brand
CaRi-Heart
Company
CARISTO DIAGNOSTICS LIMITED
Model
1.0
Published
2026-08-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
SIULong-Term Predictive Indicator For Cardiovascular Outcomes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SIULong-Term Predictive Indicator For Cardiovascular Outcomes

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250042000CaRi-HeartCaristo Diagnostics , Ltd.2026-07-28SIU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060737370017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060737370017050607373700175060737370017

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.

Contacts#

Phone, Email table
PhoneEmail
203-889-5487info@caristo.com

Regulatory Flags#

DUNS number
224183712
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
05060737370000CaRi-Plaque1.02026-01-05