Pressure Cuff Size 10

GUDID 07290016880465

The intended use of the pressure cuffs is to measure non-invasively blood pressure

VIASONIX LTD

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• Primary Device ID: 07290016880465
• NIH Device Record Key: 675e87b8-7461-43d4-aa09-20f641db04ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pressure Cuff Size 10
• Version Model Number: Pressure Cuff Size 10
• Company DUNS: 533070236
• Company Name: VIASONIX LTD
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016880465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111416

FDA Product Code

• JOP: Transducer, Ultrasonic

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: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by VIASONIX LTD

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• 07290016880465 - Pressure Cuff Size 10: 2023-07-03 The intended use of the pressure cuffs is to measure non-invasively blood pressure
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