SCHILLER 0-13-0048

GUDID 07613365900125

SpO2 sensor for MAGLIFE Serenity

SCHILLER MEDICAL

Pulse oximeter probe, reusable

• Primary Device ID: 07613365900125
• NIH Device Record Key: 9ccae6a3-0225-4400-a029-6483e3b30c4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCHILLER
• Version Model Number: SpO2 HQ sensor, multi-application site, 5m
• Catalog Number: 0-13-0048
• 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	07613365900125 [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