ers2 Basic Software

Basic Information

• Brand Name: ers2 Basic Software
• Primary DI: 04059358001838
• Version / Model: 161801
• Company Name: ergoline GmbH
• Labeler DUNS: 314403192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-10
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: b81e4ced-b6fd-4fdb-a91b-559a98295b3d

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64339	Cardiopulmonary parameter spot-check measurement software	An application software program intended to be installed on a computer/workstation to assist a healthcare provider in the spot-check (user-initiated) measurement of a cardiovascular and/or pulmonary parameter(s) [e.g., blood pressure, electrocardiography (ECG), respiratory rate, haemoglobin oxygen saturation (SpO2)]; it might also be intended for additional physiological measurements [e.g., electromyography (EMG), galvanic skin response (GSR)]. It is intended to display, store, and allow communication of the physiological data, and may include interpretive algorithms to assist diagnosis; it is not intended for continuous bedside/intraoperative monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04059358001838	GS1