PiCCO Catheter

GUDID 04250094500641

4F Thermodilution catheter, 8cm

Pulsion Medical Systems SE

Arterial blood pressure catheter

• Primary Device ID: 04250094500641
• NIH Device Record Key: 2aaf61bd-bd55-405d-8567-defdea52d71e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PiCCO Catheter
• Version Model Number: PV2014L08N
• Company DUNS: 316093673
• Company Name: Pulsion Medical Systems SE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +490894599140
• Email: info@pulsion.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com
• Phone: +490894599140
• Email: zentrale.pulsion@getinge.com

Device Dimensions

• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter
• Catheter Gauge: 4 French
• Length: 8 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250094500641 [Primary]
GS1	14250094500648 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	24250094500645 [Package]; Contains: 14250094500648; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072364

FDA Product Code

• KRB: Probe, Thermodilution

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [PiCCO Catheter]

• 24250094500973: 4F Thermodilution catheter, 220mm
• 24250094500966: 4F Thermodilution catheter, 160mm
• 24250094500959: 4F Thermodilution catheter, 80mm
• 24250094500942: 3F Thermodilution catheter, 70mm
• 04250094500931: 5F Thermodilution catheter, 200mm
• 24250094500676: 5F Thermodilution catheter, 20cm
• 04250094500665: 4F Thermodilution catheter, 22cm
• 24250094500652: 4F Thermodilution catheter, 16cm
• 04250094500641: 4F Thermodilution catheter, 8cm
• 24250094500638: 3F Thermodilution catheter, 7cm