FDA.reportPublic FDA data

SCHILLER

Primary DI
07613365900002
Brand
SCHILLER
Company
SCHILLER MEDICAL
Model
MAGLIFE Serenity
Catalog number
1-094-9900
Device description
The Maglife Serenity is a multi-parameter patient monitor which is indicated for monitoringelectrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxidepressure at the end of expiration (EtCO2), nitrous oxide concentration (%N20), partialpressure of inspired carbon dioxide, respiratory rate (RR), noninvasiveblood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired andexpired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of oxygen (FiO2) and temperature tracking.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
07613365900002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365900002076133659000027613365900002

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

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
07613365900026SCHILLERECG sensor type IV0-13-00152016-09-21
07613365900071SCHILLERECG patient cable type IV4-15-00272016-09-22
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
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.MWI2026-06-03
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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