ECG

Basic Information

• Brand Name: ECG
• Primary DI: 00847946027124
• Version / Model: 9600-0235
• Company Name: Zoll Medical Corporation
• Labeler DUNS: 055363428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-26
• Public Version: 3
• Public Version Date: 2022-06-09
• Public Version Status: Update
• Public Device Record Key: 750762a6-b32f-4b10-86c6-84852fe7d294

Device Description

6 ECG RECTANGULAR ELECTRODES, 6 (2X3) ELECTRODES / POUCH

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
Primary	00847946027124	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 0 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 0 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: Low: 0 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 0 Percent (%) Relative Humidity