FDA.reportPublic FDA data

ers2 1CH ECG Adapter US Set 5 pcs.

Primary DI
04059358002095
Brand
ers2 1CH ECG Adapter US Set 5 pcs.
Company
ergoline GmbH
Model
707285
Published
2023-05-10
Public version status
New
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
04059358002095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059358002095040593580020954059358002095

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius65 Degrees Celsius

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
04059358001838ers2 Basic Software1618012023-05-10
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
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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