HD-ICG Electrode Convenience Kits

Basic Information

• Brand Name: HD-ICG Electrode Convenience Kits
• Primary DI: 05055679404609
• Version / Model: 7057-7005
• Catalog Number: 9057-7005
• Company Name: DELTEX MEDICAL LIMITED
• Labeler DUNS: 225232610
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-22
• Public Version: 2
• Public Version Date: 2023-06-12
• Public Version Status: Update
• Public Device Record Key: 25ca520b-da0b-4cdb-8121-2a195904e0a1

Device Description

The CardioQ-EDM+ monitor in HD-ICG mode is intended for use by medically qualified personnel to evaluate and guide optimization of hemodynamic performance in anesthetized, sedated or conscious patients; and is intended for use in the operating room, intensive care unit, emergency room, obstetrics department or other wards or departments where hemodynamic measurement is required. HD-ICG Electrode Convenience Kits contains 2 packs of 3 electrodes and a RFID smart card in a labelled clear plastic bag. The Kits are sold in a labelled shelf box which contains 5 Convenience kits.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRX	Electrode, Electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05055679404623	GS1	Kraft Cardboard	20	In Commercial Distribution
Package	05055679404616	GS1	Kraft Cardboard	5	In Commercial Distribution
Primary	05055679404609	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit