AccessGUDID - DEVICE: Deltex Medical CardioQ EDM+ (05055679404326)

GUDID

Device Identifier (DI) Information

Brand Name: Deltex Medical CardioQ EDM+
Version or Model: 9051-7166
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DELTEX MEDICAL LIMITED

Primary DI Number: 05055679404326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 225232610 *Terms of Use

Device Description: The CardioQ EDM+ is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provide clinicians with real-time information about left-ventricular blood flow.

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:	No
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?
61566	Transoesophageal vascular ultrasound monitor	A mains electricity (AC-powered) device intended to be used for monitoring cardiac output and/or fluid status through connection to a dedicated probe, which is placed in the oesophagus to measure blood flow in the descending aorta. It is based on measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle) and is displayed on the monitor as a velocity/time waveform. It is typically used during a surgical procedure or in intensive care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPW	Flowmeter, Blood, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132139	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8df576d6-f79d-4aa4-b515-e441bb0c7554
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 07, 2016