PHILIPS IntelliVue GuardianSoftware

GUDID 00884838081925

Philips Medizin Systeme Böblingen GmbH

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

Customer Support Contacts

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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