Toe Clip PPG Sensor

Basic Information

• Brand Name: Toe Clip PPG Sensor
• Primary DI: 07290016880168
• Version / Model: Toe Clip PPG Sensor
• Catalog Number: PVC0143
• Company Name: VIASONIX LTD
• Labeler DUNS: 533070236
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-19
• Public Version: 1
• Public Version Date: 2020-06-29
• Public Version Status: New
• Public Device Record Key: 86dda0e8-c18f-4138-9a15-9816224d513a
• Distribution End Date: 2020-06-19

Device Description

The Toe Clip PPG sensor is designed in shape as a clothespin, primarily to fit comfortably to the toes. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOP	Transducer, Ultrasonic	Cardiovascular	870.2880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40761	General-purpose ultrasound imaging system	A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016880168	GS1

Premarket Submissions

Submission Number	Supplement Number
K111416	000