SureSigns VM1 863264

GUDID 00884838028906

Philips Medical Systems

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00884838028906
• NIH Device Record Key: 02136ee4-66f5-4828-85fd-19cf1b6786c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureSigns VM1
• Version Model Number: 863264
• Catalog Number: 863264
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• 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: false
• Serial Number: true
• 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	00884838028906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090483

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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: 2020-02-06
• Device Publish Date: 2016-10-03

On-Brand Devices [SureSigns VM1]

• 00884838028906: 863264
• 00884838009691: 863266
• 00884838009684: 863265