I2S6 Doppler Probe

GUDID 5055679401547

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 refl

DELTEX MEDICAL LIMITED

Transoesophageal vascular ultrasound probe
Primary Device ID5055679401547
NIH Device Record Key8a008f4b-f413-49ed-bfaa-87b2af627683
Commercial Distribution StatusIn Commercial Distribution
Brand NameI2S6 Doppler Probe
Version Model Number9090-7015
Company DUNS225232610
Company NameDELTEX MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401243774837
Emailcustomer.services@deltexmedica
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com
Phone+4401243774837
Emailcustomer.services@deltexmedical.com

Device Dimensions

Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter
Length89 Centimeter
Depth50 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055679400076 [Primary]
GS15055679401547 [Package]
Contains: 05055679400076
Package: Kraft Cardboard [5 Units]
In Commercial Distribution
GS15055679401714 [Package]
Package: Kraft Cardboard [18 Units]
In Commercial Distribution
GS15055679401721 [Package]
Package: Kraft Cardboard [19 Units]
In Commercial Distribution
GS15055679401738 [Package]
Package: Kraft Cardboard [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPTProbe, Blood-Flow, Extravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-07

Devices Manufactured by DELTEX MEDICAL LIMITED

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5055679401547 - I2S6 Doppler Probe2018-07-06A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the frequency of the refl
5055679401547 - I2S6 Doppler Probe2018-07-06 A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the
5055679401745 - I2P24 Doppler Probe2018-07-06 A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the
05055679400090 - I2C72 Doppler Probe2018-07-06 A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the
05055679404319 - Deltex Medical CardioQ EDM2018-07-06 The CardioQ EDM is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provi
05055679404326 - Deltex Medical CardioQ EDM+2018-07-06 The CardioQ EDM+ is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provi
5055679406122 - KDP72 Doppler Probe2018-07-06 A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the

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