SCHILLER MEDICAL

Address:4, RUE LOUIS PASTEUR,WISSEMBOURG Bas-Rhin,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (10)

Premarket Exempt

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SCHILLER - 07613365900002 Catalog Number : 1-094-9900

Device Description : The Maglife Serenity is a multi-parameter patient monitor which is indicated for 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.

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900019 Catalog Number : 1-096-9900

Device Description : MAGSCREEN Serenity is the remote display for MAGLIFE Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900026 Catalog Number : 0-13-0015

Device Description : ECG Sensor for MAGLIFE Serenity.

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900033 Catalog Number : 0-13-0025

Device Description : SpO2 Sensor for MAGLIFE Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900040 Catalog Number : 0-13-0038

Device Description : SpO2 Adult sensor for MAGLIFE Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900057 Catalog Number : 0-13-0039

Device Description : SpO2 sensor for Children, for MAGLIFE Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900064 Catalog Number : 0-13-0041

Device Description : Universal SpO2 sensor for MAGLIFE Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900071 Catalog Number : 4-15-0027

Device Description : ECG Patient cable for MAGLIFE Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900088 Catalog Number : 9-01-0187

Device Description : Optical temperature probe for MAGLIFE Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

SCHILLER - 07613365900101 Catalog Number : 0-13-0040

Device Description : SpO2 Sensor for Maglife Serenity

Device Class : 2

Duns Number: 264351388

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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