PulsioFlex

GUDID 04250094501525

Pulsion Medical Systems SE

Invasive arterial pressure cardiac output/oximetry monitor

• Primary Device ID: 04250094501525
• NIH Device Record Key: 1cb101da-739e-401f-8e4d-fd8df71b9e72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PulsioFlex
• Version Model Number: PC4000
• Company DUNS: 316093673
• Company Name: Pulsion Medical Systems SE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49894599140
• Email: info@pulsion.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +49894599140
• Email: zentrale.pulsion@getinge.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250094501525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122121

FDA Product Code

• DXG: Computer, Diagnostic, Pre-Programmed, Single-Function

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-10

Devices Manufactured by Pulsion Medical Systems SE

• 24250094500089 - PiCCO Monitoring Kit: 2019-01-23
• 24250094500171 - PiCCO Monitoring Kit: 2019-01-23
• 24250094500188 - PiCCO Monitoring Kit: 2019-01-23
• 04250094500153 - Injectate temperature sensor housing: 2018-07-06 Injectate temperature sensor housing PV4046
• 24250094500638 - PiCCO Catheter: 2018-07-06 3F Thermodilution catheter, 7cm
• 04250094500641 - PiCCO Catheter: 2018-07-06 4F Thermodilution catheter, 8cm
• 24250094500652 - PiCCO Catheter: 2018-07-06 4F Thermodilution catheter, 16cm
• 04250094500665 - PiCCO Catheter: 2018-07-06 4F Thermodilution catheter, 22cm