Vital-Trac

Primary DI
00850070776073
Brand
Vital-Trac
Company
Mindset Medical Inc.
Model
RROEMEMB
Device description
RR Software OEM Embedded
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory RateCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250078000Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)Mindset Medical, Inc.2025-05-30QME

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070776073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070776073008500707760738500707760730850070776073

GMDN Terms#

Term, Definition table
TermDefinition
Camera application softwareA data program designed for use in, or together with, a camera (e.g., a digital camera or video recorder) so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119487830
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850070776028Vital-TracPROEMEMB2025-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070776028Vital-TracMindset Medical Inc.QME2025-05-23
50607514500009Vital SignsOXEHEALTH LIMITEDQME2025-01-21