GE Healthcare ELT-PWIEC-NEO-150

GUDID 29005531002559

Pre-wired ECG Electrode

Leonhard Lang GmbH

Neonatal electrocardiographic electrode

• Primary Device ID: 29005531002559
• NIH Device Record Key: 2c526689-d23b-46f4-a8b7-f13d0b0007ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE Healthcare
• Version Model Number: PD50-SFC
• Catalog Number: ELT-PWIEC-NEO-150
• Company DUNS: 302846407
• Company Name: Leonhard Lang GmbH
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09005531002555 [Unit of Use]
GS1	19005531002552 [Primary]
GS1	29005531002559 [Package]; Contains: 19005531002552; Package: Box [50 Units]; In Commercial Distribution
GS1	39005531002556 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-09-14

On-Brand Devices [GE Healthcare]

• 39005531504609: Adult Direct-Wired Disposable Defibrillation / Pacing Electrodes
• 29005531002573: ECG Electrode
• 29005531002566: ECG Electrode
• 29005531002559: Pre-wired ECG Electrode
• 29005531002542: ECG Electrode
• 29005531002535: ECG Electrode