FDA.reportPublic FDA data

ers2 Basic Software

Primary DI
04059358001838
Brand
ers2 Basic Software
Company
ergoline GmbH
Model
161801
Published
2023-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059358001838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059358001838040593580018384059358001838

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary parameter spot-check measurement softwareAn 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 variety of both cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), respiratory rate]; 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314403192
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059358002224optibike basic1960012023-05-12
04059358001746ers2 1CH Telemetry Transmitter1618472023-05-10
04059358001753ers2 ECG Receiver1618352023-05-10
04059358001760ers2 1CH ECG Adapter1618362023-05-10
04059358001777ers2 1CH ECG Transmitter Set (Adapter)1618462023-05-10
04059358001821ergoselect 11950012023-05-10
04059358002095ers2 1CH ECG Adapter US Set 5 pcs.7072852023-05-10
04059358002101ers2 1CH ECG Adapter US Set 10 pcs.7072862023-05-10
04059358002118ers2 1CH ECG Adapter US Set 20 pcs.7072872023-05-10
04059358002231ergoselect 121920012023-05-10
04059358002248ergoselect 101930012023-05-10
04059358002484ergocar basic1710012023-05-10
04059358002491ergocar PC1711012023-05-10
04059358002699Seat Ergometer ergoselect 150 P child16121702023-05-10
04059358003733ergoselect 41910032023-05-10
04059358003740ergoselect 51910042023-05-10
04059358000015ERGOMETER EBIKE BASIC US2017911-2022016-09-24
04059358000022ERGOMETER EBIKE BASIC US & BP2017911-2042016-09-24
04059358000039ERGOMETER EBIKE COMFORT US2017911-2062016-09-24
04059358000046ERGOMETER EBIKE COMFORT US & BP2017911-2082016-09-24

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Primary DI, Brand, Company table
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04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
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B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyDRG2025-12-10
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
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