SCHILLER 0-13-0049

GUDID 07613365900132

SpO2 sensor for MAGLIFE Serenity

SCHILLER MEDICAL

Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable

• Primary Device ID: 07613365900132
• NIH Device Record Key: c7193452-23a8-4180-8267-68d8fdece821
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCHILLER
• Version Model Number: SpO2 HQ sensor, multi-application site, 10m for ML
• Catalog Number: 0-13-0049
• Company DUNS: 264351388
• Company Name: SCHILLER MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr
• Phone: +33388633600
• Email: court.goehry@schiller.fr

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365900132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023195

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-10

On-Brand Devices [SCHILLER]

• 07613365900132: SpO2 sensor for MAGLIFE Serenity
• 07613365900125: SpO2 sensor for MAGLIFE Serenity
• 07613365900118: SpO2 sensor for MAGLIFE Serenity
• 07613365900101: SpO2 Sensor for Maglife Serenity
• 07613365900088: Optical temperature probe for MAGLIFE Serenity
• 07613365900071: ECG Patient cable for MAGLIFE Serenity
• 07613365900064: Universal SpO2 sensor for MAGLIFE Serenity
• 07613365900057: SpO2 sensor for Children, for MAGLIFE Serenity
• 07613365900040: SpO2 Adult sensor for MAGLIFE Serenity
• 07613365900033: SpO2 Sensor for MAGLIFE Serenity
• 07613365900026: ECG Sensor for MAGLIFE Serenity.
• 07613365900019: MAGSCREEN Serenity is the remote display for MAGLIFE Serenity
• 07613365900002: The Maglife Serenity is a multi-parameter patient monitor which is indicated for monitoring elec