ers2 Basic Software

GUDID 04059358001838

ergoline GmbH

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• Primary Device ID: 04059358001838
• NIH Device Record Key: b81e4ced-b6fd-4fdb-a91b-559a98295b3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ers2 Basic Software
• Version Model Number: 161801
• Company DUNS: 314403192
• Company Name: ergoline 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059358001838 [Primary]

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2023-05-18
• Device Publish Date: 2023-05-10

Devices Manufactured by ergoline GmbH

• 04059358002224 - optibike basic: 2023-05-22
• 04059358001746 - ers2 1CH Telemetry Transmitter: 2023-05-18
• 04059358001753 - ers2 ECG Receiver: 2023-05-18
• 04059358001760 - ers2 1CH ECG Adapter: 2023-05-18
• 04059358001777 - ers2 1CH ECG Transmitter Set (Adapter): 2023-05-18
• 04059358001821 - ergoselect 1: 2023-05-18
• 04059358001838 - ers2 Basic Software: 2023-05-18
• 04059358001838 - ers2 Basic Software: 2023-05-18
• 04059358002095 - ers2 1CH ECG Adapter US Set 5 pcs.: 2023-05-18