HD-ICG Electrode Convenience Kits 7057-7005

GUDID 05055679404623

The CardioQ-EDM+ monitor in HD-ICG mode is intended for use by medically qualified personnel to evaluate and guide optimization of hemodynamic perform

DELTEX MEDICAL LIMITED

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use

• Primary Device ID: 05055679404623
• NIH Device Record Key: 25ca520b-da0b-4cdb-8121-2a195904e0a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HD-ICG Electrode Convenience Kits
• Version Model Number: 7057-7005
• Catalog Number: 7057-7005
• Company DUNS: 225232610
• Company Name: DELTEX MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055679404609 [Primary]
GS1	05055679404616 [Package]; Contains: 05055679404609; Package: Kraft Cardboard [5 Units]; In Commercial Distribution
GS1	05055679404623 [Package]; Contains: 05055679404616; Package: Kraft Cardboard [20 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-22

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: 2019-03-11The CardioQ-EDM+ monitor in HD-ICG mode is intended for use by medically qualified personnel to evaluate and guide optimization of hemodynamic perform
• 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 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