IVY BIOMEDICAL

Basic Information

• Brand Name: IVY BIOMEDICAL
• Primary DI: 10653405004448
• Version / Model: 590323
• Catalog Number: 590323
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2021-03-26
• Public Version Status: Update
• Public Device Record Key: c0162476-c6fb-45f3-8b46-dbc3ccc2653b
• Distribution End Date: 2021-03-25

Device Description

IVY BIOMEDICAL, ECG CABLES

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKD	CABLE, ELECTRODE	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10653405004448	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -4 – 131 Degrees Fahrenheit