Deltex Medical CardioQ EDM

GUDID 05055679404319

The CardioQ EDM is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provide clinicians with rea

DELTEX MEDICAL LIMITED

Transoesophageal vascular ultrasound monitor

• Primary Device ID: 05055679404319
• NIH Device Record Key: c4c9bc8b-e902-499b-ac12-411b309da2ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deltex Medical CardioQ EDM
• Version Model Number: 9051-7057
• Company DUNS: 225232610
• Company Name: DELTEX MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401243774837
• Email: customer.services@deltexmedica

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055679404319 [Primary]
GS1	5055679406108 [Package]; Package: Cardboard Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111542

FDA Product Code

• DPW: Flowmeter, Blood, Cardiovascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

Devices Manufactured by DELTEX MEDICAL LIMITED

• 5055679400748 - DP240 Doppler Probe: 2020-02-12 A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the
• 05055679404623 - HD-ICG Electrode Convenience Kits: 2019-03-11 The CardioQ-EDM+ monitor in HD-ICG mode is intended for use by medically qualified personnel to evaluate and guide optimization
• 5055679401547 - I2S6 Doppler Probe: 2018-07-06 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 Probe: 2018-07-06 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 Probe: 2018-07-06 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 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 provide clinicians with rea
• 05055679404319 - 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
• 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 Probe: 2018-07-06 A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the