IGuerburn

GUDID 06947679701194

Shenzhen Pump Medical System Co., Ltd.

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: 06947679701194
• NIH Device Record Key: f23f6a4e-c8c7-4e01-beea-bd53f3258fb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IGuerburn
• Version Model Number: BE6034
• Company DUNS: 421184626
• Company Name: Shenzhen Pump Medical System Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947679701194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151258

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-01

On-Brand Devices [IGuerburn]

• 06947679701194: BE6034
• 06947679701170: SF1400B