Electronic Blood Pressure Monitor

GUDID 06972040110794

The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

Shenzhen AOJ Medical Technology Co., Ltd

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• Primary Device ID: 06972040110794
• NIH Device Record Key: 0092084b-19ef-4610-9523-82d31beb3fd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electronic Blood Pressure Monitor
• Version Model Number: AOJ-35D
• Company DUNS: 554409093
• Company Name: Shenzhen AOJ Medical Technology Co., Ltd
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972040110794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191180

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-08
• Device Publish Date: 2021-10-29

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• 06972040110794 - Electronic Blood Pressure Monitor: 2021-11-08The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
• 06972040110794 - Electronic Blood Pressure Monitor: 2021-11-08 The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate