CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 30885380074497
• Version / Model: E501FATR
• Catalog Number: E501FATR
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 6
• Public Version Date: 2019-07-01
• Public Version Status: Update
• Public Device Record Key: a2a2331e-7193-4bbd-86b7-e6a7d6942850
• Distribution End Date: 2019-07-01

Device Description

Monitoring Electrode, RT Snap, Foam, Tear Drop

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• 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	50885380074491	GS1	CASE	10	Not in Commercial Distribution	2019-07-01
Package	20885380074490	GS1	BOX	20	Not in Commercial Distribution	2019-07-01
Primary	30885380074497	GS1
Unit of Use	10885380074493	GS1

Premarket Submissions

Submission Number	Supplement Number
K020003	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius