GE Healthcare

Basic Information

• Brand Name: GE Healthcare
• Primary DI: 19005531504605
• Version / Model: DF55N
• Catalog Number: 2059145-001
• Company Name: Leonhard Lang GmbH
• Labeler DUNS: 302846407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cf3545ff-6403-476a-854a-b237b313601c

Device Description

Adult Direct-Wired Disposable Defibrillation / Pacing Electrodes

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
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
45806	Multifunction cardiac electrode, adult	A non-sterile electrical conductor designed to be applied to an adult patient for automatic or manual defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s), defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	39005531504609	GS1	box	12	In Commercial Distribution
Package	29005531504602	GS1	box	10	In Commercial Distribution
Primary	19005531504605	GS1

Premarket Submissions

Submission Number	Supplement Number
K072233	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius