Pressure Cuff Size 1.9

GUDID 07290016880502

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

VIASONIX LTD

Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable Blood pressure cuff, reusable

• Primary Device ID: 07290016880502
• NIH Device Record Key: b5a720a9-b9cc-4d1e-9680-3591402d9d60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pressure Cuff Size 1.9
• Version Model Number: Pressure Cuff Size 1.9
• 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	07290016880502 [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: 2023-07-07
• Device Publish Date: 2023-06-29

Devices Manufactured by VIASONIX LTD

• 07290016880489 - Pressure Cuff Size 12L: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880496 - Pressure Cuff Size 2.5: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880502 - Pressure Cuff Size 1.9: 2023-07-07The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880502 - Pressure Cuff Size 1.9: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880519 - Pressure Cuff Size 1.6: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880526 - Pressure Cuff Size 7: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880465 - Pressure Cuff Size 10: 2023-07-03 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880472 - Pressure Cuff Size 12: 2023-07-03 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880397 - 4 MHz probe: 2022-08-16 4 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used i