AccessGUDID - DEVICE: I2C72 Doppler Probe (05055679400090)

GUDID

Device Identifier (DI) Information

Brand Name: I2C72 Doppler Probe
Version or Model: 9090-7017
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DELTEX MEDICAL LIMITED

Primary DI Number: 05055679400090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 225232610 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPT	Probe, Blood-Flow, Extravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073593	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 50 Centimeter
Length: 89 Centimeter

Device Record Status

Public Device Record Key: 618783ba-589e-421d-bfaf-860b536f8932
Public Version Date: April 07, 2021
Public Version Number: 4
DI Record Publish Date: September 07, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
5055679401943	5	05055679400090	In Commercial Distribution	Kraft Cardboard
5055679402117	18	5055679401943	In Commercial Distribution	Kraft Cardboard
5055679402124	19	5055679401943	In Commercial Distribution	Kraft Cardboard
5055679402131	20	5055679401943	In Commercial Distribution	Kraft Cardboard