Vital Signs

Primary DI: 50607514500009
Brand: Vital Signs
Company: OXEHEALTH LIMITED
Model: 2
Device description: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And Respiratory Rate
Published: 2025-01-21
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
Code	Name
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate	Cardiovascular	2

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
50607514500009	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifier	GTIN-14 normalized
50607514500009	50607514500009

GMDN Terms#

Term, Definition table
Term	Definition
Near-infrared camera vital sign measurement software	An application software program intended to be used to analyse images and/or videos obtained from near infrared cameras [NIR] (not included), to non-invasively measure the vital signs of a patient (e.g., pulse rate, respiratory rate). It is able to store and/or transfer data to a remote workstation, and is installed on a dedicated and/or off-the-shelf computer (e.g., desktop, laptop).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 218519521
Device count: 1
Lot or batch: true
Manufacturing date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
50607514500023	Oxevision Sleep system	2		2025-01-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00850070776073	Vital-Trac	Mindset Medical Inc.	QME	2026-03-23
00850070776028	Vital-Trac	Mindset Medical Inc.	QME	2025-05-23