GE Healthcare

Basic Information

• Brand Name: GE Healthcare
• Primary DI: 19005531002552
• Version / Model: PD50-SFC
• Catalog Number: ELT-PWIEC-NEO-150
• Company Name: Leonhard Lang GmbH
• Labeler DUNS: 302846407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2023-09-14
• Public Version: 1
• Public Version Date: 2023-09-22
• Public Version Status: New
• Public Device Record Key: 2c526689-d23b-46f4-a8b7-f13d0b0007ef

Device Description

Pre-wired ECG Electrode

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: No
• 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
17460	Neonatal electrocardiographic electrode	A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	29005531002559	GS1	Box	50	In Commercial Distribution
Primary	19005531002552	GS1
Package	39005531002556	GS1	Case	12	In Commercial Distribution
Unit of Use	09005531002555	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius