Dealmed 782015

GUDID 29005531002191

Resting ECG electrode

Leonhard Lang GmbH

Electrocardiographic electrode, single-use

• Primary Device ID: 29005531002191
• NIH Device Record Key: 886b6450-d994-4a1c-8bdb-a864c0f47d59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dealmed
• Version Model Number: RT24
• Catalog Number: 782015
• Company DUNS: 302846407
• Company Name: Leonhard Lang GmbH
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09005531002197 [Unit of Use]
GS1	19005531002194 [Primary]
GS1	29005531002191 [Package]; Contains: 19005531002194; Package: box [1000 Units]; In Commercial Distribution
GS1	39005531002198 [Package]; Package: case [4000 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: 2021-04-15
• Device Publish Date: 2021-04-07

Devices Manufactured by Leonhard Lang GmbH

• 29005531000142 - SKINTACT: 2024-08-01 ECG Electrode
• 29005531001125 - SKINTACT: 2024-08-01 ECG Electrode
• 29005531000432 - SKINTACT: 2024-04-25 Pre-wired ECG Electrode
• 29005531002535 - GE Healthcare: 2023-09-22 ECG Electrode
• 29005531002542 - GE Healthcare: 2023-09-22 ECG Electrode
• 29005531002559 - GE Healthcare: 2023-09-22 Pre-wired ECG Electrode
• 29005531002566 - GE Healthcare: 2023-09-22 ECG Electrode
• 29005531002573 - GE Healthcare: 2023-09-22 ECG Electrode