EndoPATx

Basic Information

• Brand Name: EndoPATx
• Primary DI: 07290109225425
• Version / Model: EndoPATx
• Catalog Number: AS1650007
• Company Name: ITAMAR MEDICAL LTD
• Labeler DUNS: 531857076
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-27
• Public Version: 1
• Public Version Date: 2023-05-05
• Public Version Status: New
• Public Device Record Key: a16f96c3-fa38-4c73-ba25-2c248be5b54e

Device Description

EndoPATx Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQK	Computer, Diagnostic, Programmable	Cardiovascular	870.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47687	Cardiovascular-risk peripheral arterial tonometry system	An electrically-powered assembly of devices designed to assess peripheral artery endothelial dysfunction (poor vasodilatory response) and/or arterial stiffness through the noninvasive measurement of arterial pulsatile volume changes in the fingertip during a reactive hyperemia test (occlusion of blood flow followed by abrupt release). It typically includes a dedicated bio-sensor applied to a finger or arm and a computer/software-controlled device used to process, store, display, and help analyse peripheral arterial tone (PAT) data received from the sensor. Endothelial dysfunction is a recognized marker of sub-clinical arteriosclerosis which is used as a predictor of cardiovascular events.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109225425	GS1
Package	07290109223353	GS1	carton	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211557	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 22 – 24 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57.2 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal