DEVICE: FloWire Floppy Doppler Guide Wire ST (00184360000112)
Device Identifier (DI) Information
FloWire Floppy Doppler Guide Wire ST
1400
In Commercial Distribution
Philips Image Guided Therapy Corporation
1400
In Commercial Distribution
Philips Image Guided Therapy Corporation
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
18673 | Blood flowmeter catheter, Doppler |
A device that is a flexible tube designed for insertion within the blood vessels for the purpose of determining blood-flow velocity by measuring the ultrasonic frequency shift between the transmitted and reflected signals (Doppler principle). It typically has a ceramic crystal attached at or near its distal tip that is capable of both transmitting and receiving ultrasound signals [20 megahertz (MHz) frequency is typical]. The proximal end is connected to a Doppler blood flowmeter unit where the measurements are displayed. It is typically used for measurement of the coronary haemodynamics (e.g., blood mean and peak velocity) during coronary procedures. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQX | Wire, Guide, Catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K972762 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9a3b9d77-88fb-4509-9791-e8cdc25115a7
February 28, 2022
5
August 24, 2016
February 28, 2022
5
August 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(800) 228-4728
IGTD.CustomerInquiry@philips.com
IGTD.CustomerInquiry@philips.com