Disk PPG sensor

GUDID 07290016880175

The disk PPG sensor is round shaped and attaches to the skin with an adhesive sticker. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures, venous reflux testing, or other peripheral vascular diagnosis tests.

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880175
• NIH Device Record Key: d7a9b714-8203-4ea0-a469-1e72775ca8d9
• Commercial Distribution Discontinuation: 2020-06-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Disk PPG sensor
• Version Model Number: Disk PPG sensor
• 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: false
• Serial Number: true
• 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	07290016880175 [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: 2020-06-29
• Device Publish Date: 2020-06-19

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: 2023-07-07 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