Wireless Pulse Oximetry Sensor for TeslaDUO 5010101

GUDID 04255629200553

MIPM Mammendorfer Institut für Physik und Medizin GmbH

Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry Patient monitoring system module, pulse oximetry

• Primary Device ID: 04255629200553
• NIH Device Record Key: cbb21902-f00d-4a9e-b9f9-2e33b1f55505
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wireless Pulse Oximetry Sensor for TeslaDUO
• Version Model Number: Wireless Pulse Oximetry Sensor for TeslaDUO
• Catalog Number: 5010101
• Company DUNS: 324416379
• Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com
• Phone: +49814592090
• Email: info@mipm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04255629200553 [Primary]
HIBCC	EMIP50101010 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153739

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-02
• Device Publish Date: 2024-01-25

Devices Manufactured by MIPM Mammendorfer Institut für Physik und Medizin GmbH

• 04255629200508 - MRI Patient Monitor TeslaDUO: 2024-02-02 The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.
• 04255629200515 - TeslaDUO Remote Control: 2024-02-02
• 04255629200522 - Trolley TeslaDUO including MFI: 2024-02-02
• 04255629200553 - Wireless Pulse Oximetry Sensor for TeslaDUO: 2024-02-02
• 04255629200553 - Wireless Pulse Oximetry Sensor for TeslaDUO: 2024-02-02
• 04255629200355 - SpO2 Finger Adapter M-Flex: 2023-12-22
• 04255629200379 - SpO2 Clip Adapter: 2023-12-22
• 04255629200874 - SpO2 Adapter, small, 10/box: 2023-12-22
• 04255629200881 - SpO2 Adapter, medium, 10/box: 2023-12-22