Detachable PPG Clip sensor

GUDID 07290016880441

The detachable PPG Clip sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests

VIASONIX LTD

General-purpose ultrasound imaging system
Primary Device ID07290016880441
NIH Device Record Key073cc80e-14f8-4136-9922-15d651d640c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetachable PPG Clip sensor
Version Model NumberDetachable PPG Clip sensor
Company DUNS533070236
Company NameVIASONIX LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016880441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOPTransducer, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-06
Device Publish Date2024-12-27

Devices Manufactured by VIASONIX LTD

07290016880441 - Detachable PPG Clip sensor2025-01-06The detachable PPG Clip sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortably to the fingers. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests
07290016880441 - Detachable PPG Clip sensor2025-01-06 The detachable PPG Clip sensor is similar in enclosure to a standard pulse oximeter. It is designed primarily to fit comfortabl
07290016880533 - Falcon/Xpress2025-01-06 The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.
07290016880489 - Pressure Cuff Size 12L2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
07290016880496 - Pressure Cuff Size 2.52023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
07290016880502 - Pressure Cuff Size 1.92023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
07290016880519 - Pressure Cuff Size 1.62023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
07290016880526 - Pressure Cuff Size 72023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
07290016880465 - Pressure Cuff Size 102023-07-03 The intended use of the pressure cuffs is to measure non-invasively blood pressure

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