PulsioFlex

Basic Information

• Brand Name: PulsioFlex
• Primary DI: 04250094501525
• Version / Model: PC4000
• Company Name: Pulsion Medical Systems SE
• Labeler DUNS: 316093673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-10
• Public Version: 5
• Public Version Date: 2021-10-13
• Public Version Status: Update
• Public Device Record Key: 1cb101da-739e-401f-8e4d-fd8df71b9e72

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: MR Unsafe
• 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
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	870.1435	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42873	Invasive arterial pressure cardiac output/oximetry monitor	A mains electricity (AC-powered) device, which may have internal rechargeable batteries, designed to continuously measure and display arterial pressure cardiac output (APCO) [minimally-invasive cardiac output estimation from arterial blood pressure waveforms] and haemoglobin oxygen saturation (e.g., SpO2) when connected to an extravascular blood pressure transducer linked to a peripheral arterial line, and to a pulse oximeter or an oximetry catheter. It is typically used in the operating room or intensive care unit (ICU) and may also calculate other haemodynamic parameters including cardiac index, stroke volume, and/or systemic vascular resistance.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250094501525	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122121	000
K172259	000