PHILIPS IntelliVue GuardianSoftware

GUDID 00884838081925

Philips Medizin Systeme Böblingen GmbH

Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software

• Primary Device ID: 00884838081925
• NIH Device Record Key: 3fc3ae23-a28b-4ca3-b7e2-0304a63b9ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHILIPS IntelliVue GuardianSoftware
• Version Model Number: C
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838081925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151736

FDA Product Code

• DXJ: DISPLAY, CATHODE-RAY TUBE, MEDICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-12-01

On-Brand Devices [PHILIPS IntelliVue GuardianSoftware]

• 00884838085718: D
• 00884838081925: C
• 00884838094253: E