FDA.reportPublic FDA data

SCHILLER

Primary DI
07613365900026
Brand
SCHILLER
Company
SCHILLER MEDICAL
Model
ECG sensor type IV
Catalog number
0-13-0015
Device description
ECG Sensor for MAGLIFE Serenity.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023195000MAGLIFE C/MAGLIFE C PLUSSchiller Medical S.A.2003-06-03MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613365900026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365900026076133659000267613365900026

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33388633600court.goehry@schiller.fr

Regulatory Flags#

DUNS number
264351388
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613365900071SCHILLERECG patient cable type IV4-15-00272016-09-22
07613365900002SCHILLERMAGLIFE Serenity 1-094-99002016-09-21
07613365900019SCHILLERMAGSCREEN Serenity1-096-99002016-09-21
07613365900033SCHILLERSpO2 sensor Y 4,2m 0-13-00252016-09-22
07613365900040SCHILLERSpO2 sensor Adult0-13-00382016-09-22
07613365900057SCHILLERSpO2 sensor Children0-13-00392016-09-22
07613365900064SCHILLERSpO2 sensor Y 5,5m0-13-00412016-09-22
07613365900101SCHILLERSpO2 Sensor wireless0-13-00402016-11-04
07613365900118SCHILLERSpO2 HQ sensor, multi-application site, 5m0-13-00472017-05-10
07613365900125SCHILLERSpO2 HQ sensor, multi-application site, 5m0-13-00482017-05-10
07613365900132SCHILLERSpO2 HQ sensor, multi-application site, 10m for ML0-13-00492017-05-10
07613365900088SCHILLERTemp. Probe optical skin9-01-01872016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-07-21
03615041990578Capsule SurveillancePhilips North America LLCMWI2026-07-14
08684906452600Arc SystemM2AN DIGITAL HEALTH INC.MWI2026-06-29
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04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201017Gas Sample Line SetMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
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