FDA.reportPublic FDA data

SCHILLER

Primary DI
07613365900019
Brand
SCHILLER
Company
SCHILLER MEDICAL
Model
MAGSCREEN Serenity
Catalog number
1-096-9900
Device description
MAGSCREEN Serenity is the remote display 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
07613365900019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613365900019076133659000197613365900019

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 Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
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
07613365900002SCHILLERMAGLIFE Serenity 1-094-99002016-09-21
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
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27