GE Healthcare 2059145-001

GUDID 39005531504609

Adult Direct-Wired Disposable Defibrillation / Pacing Electrodes

Leonhard Lang GmbH

Multifunction cardiac electrode, adult

• Primary Device ID: 39005531504609
• NIH Device Record Key: cf3545ff-6403-476a-854a-b237b313601c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE Healthcare
• Version Model Number: DF55N
• Catalog Number: 2059145-001
• Company DUNS: 302846407
• Company Name: Leonhard Lang GmbH
• Device Count: 1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	19005531504605 [Primary]
GS1	29005531504602 [Package]; Contains: 19005531504605; Package: box [10 Units]; In Commercial Distribution
GS1	39005531504609 [Package]; Contains: 29005531504602; Package: box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072233

FDA Product Code

• MKJ: Automated External Defibrillators (Non-Wearable)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-04-14

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