Philips Blood Pressure Monitor

GUDID 00075020056382

Philips Medical Systems Nederland B.V.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00075020056382
• NIH Device Record Key: 3a8f12ae-52bb-4cfe-a2bf-ebd43e008365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Blood Pressure Monitor
• Version Model Number: DL8760
• Company DUNS: 489844773
• Company Name: Philips Medical Systems Nederland B.V.
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075020056382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131395

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2019-11-08
• Device Publish Date: 2016-11-21

On-Brand Devices [Philips Blood Pressure Monitor]

• 00075020056399: DL8765
• 00075020056382: DL8760