PiCCO Monitoring Kit

Basic Information

• Brand Name: PiCCO Monitoring Kit
• Primary DI: 04250094500085
• Version / Model: PV8115
• Company Name: Pulsion Medical Systems SE
• Labeler DUNS: 316093673
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 5
• Public Version Date: 2021-10-04
• Public Version Status: Update
• Public Device Record Key: 844774fd-a854-4186-8103-6653232b4a26
• Distribution End Date: 2021-10-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRB	Probe, Thermodilution	Cardiovascular	870.1915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45275	Invasive blood pressure transducer set	A collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24250094500089	GS1		25	Not in Commercial Distribution	2021-10-01
Primary	04250094500085	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K991886	000