CARDIOTRONIC

Basic Information

• Brand Name: CARDIOTRONIC
• Primary DI: 04260451441043
• Version / Model: ICON
• Company Name: Osypka Medical GmbH
• Labeler DUNS: 317157048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 1
• Public Version Date: 2021-05-10
• Public Version Status: New
• Public Device Record Key: 2163bc02-f1d9-4bf6-b390-4e7d5f46e2d6

Device Description

ICON Non-invasive Hemodynamic Cardiometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
DSB	Plethysmograph, Impedance	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17496	Impedance cardiac output unit	A device used to quantify cardiac output from measurements of the thoracic impedance changes associated with cardiac activity. It typically consists of electrodes appropriate to measure the thoracic impedance and an electronic unit that processes the data and displays the cardiac output values. This device only measures in real time and does not record data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260451441043	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius