989803128531

GUDID 30884838010186

Philips Medizin Systeme Böblingen GmbH

Pulse oximeter probe, single-use

• Primary Device ID: 30884838010186
• NIH Device Record Key: 825e7457-ac1d-4a3f-b161-25d1e194c95a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 989803128531
• Catalog Number: 989803128531
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	30884838010186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042306

FDA Product Code

• DQA: Oximeter

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: 2016-11-22

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• 00884838070790 - Philips IntelliVue Patient Monitoring: 2021-12-07 The IntelliVue MX850 Patient Monitor has an optically-bonded 22 inch (547 mm) LCD (TFT) widescreen display with projected capaci
• 00884838083332 - Philips IntelliVue Patient Monitoring: 2021-12-07 The IntelliVue MX750 Patient Monitor has an optically-bonded 19 inch (469 mm) LCD (TFT) widescreen display with projected capaci
• 00884838086982 - Philips IntelliVue Patient Monitoring: 2021-12-07 The IntelliVue FMX-4 Flexible Module Rack provides 4 module slots for use with individual measurement modules and the recorder.
• 00884838010826 - Cardiac Output Adapter Cable: 2021-11-05
• 00884838102705 - NA: 2021-11-04