Philips IntelliVue XDS Application

GUDID 00884838059313

Philips Medizin Systeme Böblingen GmbH

Bedside information system

• Primary Device ID: 00884838059313
• NIH Device Record Key: 5621b589-f679-48d8-bb53-cf69862229c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips IntelliVue XDS Application
• Version Model Number: M
• Company DUNS: 314101143
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838059313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150310

FDA Product Code

• MSX: SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

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: 2017-08-25

Devices Manufactured by Philips Medizin Systeme Böblingen GmbH

• 00884838117440 - NOUN: 2025-08-29 36" patient cable (standard), for use only with the DigiTrak XT recorder
• 00884838120303 - MR Patient Care Universal Gating Interface: 2025-08-01 Gating cable for use between any Expression MR patient monitor and any wired or wireless MRI system accessories.
• 00884838126411 - Leads: 2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs, 10-lead, AAMI color-coding, 3mm needle
• 00884838126428 - Leads: 2025-07-24 Wireless PIM Leadwires for PageWriter TC Series Cardiographs,10-lead, IEC color-coding, 4mm banana
• 00884838114937 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114951 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114975 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2
• 00884838114999 - NIBP Cuffs: 2025-07-11 Neonatal Soft Single-Patient Cuff Size#2