I2P24 Doppler Probe

Basic Information

• Brand Name: I2P24 Doppler Probe
• Primary DI: 05055679400083
• Version / Model: 9090-7013
• Company Name: DELTEX MEDICAL LIMITED
• Labeler DUNS: 225232610
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 13c07d11-74ae-4d75-aaa3-dcd7099b478b

Device Description

A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the frequency of the reflected ultrasound waves caused by the moving blood cells are translated by the CardioQ™ into a real time display of the velocity of the blood against time. Analysis of the waveform provides information on a range of cardiac parameters to be derived.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	870.2120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61565	Transoesophageal vascular ultrasound probe	A device intended to be inserted into the oesophagus, orally or nasally, to continuously measure blood flow in the descending aorta by ultrasonic Doppler technology for assessment of cardiac output and/or fluid status. It is typically constructed of flexible materials (e.g., polymers) and has a metal conducting core; it has multiple sensors at the distal end and a connector at the proximal end. It is typically used during general anaesthesia or in intensive care. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	5055679401745	GS1	Kraft Cardboard	5	In Commercial Distribution
Primary	05055679400083	GS1
Package	5055679401912	GS1	Kraft Cardboard	18	In Commercial Distribution
Package	5055679401929	GS1	Kraft Cardboard	19	In Commercial Distribution
Package	5055679401936	GS1	Kraft Cardboard	20	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073593	000

Device Sizes

Type	Value	Unit	Text
Depth	50	Centimeter
Length	89	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius