PiCCO Monitoring Kit

GUDID 24250094500171

Pulsion Medical Systems SE

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• Primary Device ID: 24250094500171
• NIH Device Record Key: b7ccdca2-0d94-4554-8352-68368232d7d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PiCCO Monitoring Kit
• Version Model Number: PV8115CVP
• 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: +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	04250094500177 [Primary]
GS1	24250094500171 [Package]; Contains: 04250094500177; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991886

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: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-03-13

On-Brand Devices [PiCCO Monitoring Kit]

• 24250094500188: PV8103
• 24250094500171: PV8115CVP
• 24250094500089: PV8115