PiCCO Catheter

GUDID 04250094500931

5F Thermodilution catheter, 200mm

Pulsion Medical Systems SE

Arterial blood pressure catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter Thermal dilution peripheral artery catheter

• Primary Device ID: 04250094500931
• NIH Device Record Key: 690432bf-2341-4878-b665-d21c6e6147ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PiCCO Catheter
• Version Model Number: PV2015L20-A
• 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: 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: +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 Dimensions

• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter
• Catheter Gauge: 5 French
• Length: 200 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250094500931 [Primary]
GS1	14250094500938 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	24250094500935 [Package]; Contains: 14250094500938; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171620

FDA Product Code

• KRB: Probe, Thermodilution

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-06

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