AccessGUDID - DEVICE: Fingerclip PPG sensor (07290016880182)

GUDID

Device Identifier (DI) Information

Brand Name: Fingerclip PPG sensor
Version or Model: Fingerclip PPG sensor
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: VIASONIX LTD

Primary DI Number: 07290016880182
Issuing Agency: GS1
Commercial Distribution End Date: June 19, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 533070236 *Terms of Use

Device Description: The Fingerclip PPG 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOP	Transducer, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111416	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d829c78-cd78-4902-881b-cf69f74af1b6
Public Version Date: June 29, 2020
Public Version Number: 1
DI Record Publish Date: June 19, 2020