SpO2 Finger Adapter M-Flex 5010049

GUDID 04255629200355

MIPM Mammendorfer Institut für Physik und Medizin GmbH

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• Primary Device ID: 04255629200355
• NIH Device Record Key: 4e83b4d7-fdfa-4f8b-8d29-945d9f084bb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Finger Adapter M-Flex
• Version Model Number: 5010049
• Catalog Number: 5010049
• Company DUNS: 324416379
• Company Name: MIPM Mammendorfer Institut für Physik und Medizin GmbH
• Device Count: 5
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	04255629200355 [Direct Marking]
GS1	04255629200362 [Primary]
HIBCC	EMIP50100491 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142032

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: 2023-12-22
• Device Publish Date: 2023-12-14

On-Brand Devices [SpO2 Finger Adapter M-Flex]

• EMIP50100490: 5010049
• 04255629200355: 5010049