Finger Plethysmograph (Models TS3 and TS4)

Basic Information

• Brand Name: Finger Plethysmograph (Models TS3 and TS4)
• Primary DI: 00817980021198
• Version / Model: Model TS-4
• Catalog Number: V83-0006
• Company Name: VASOMEDICAL, INC.
• Labeler DUNS: 197210248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-29
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: cda57a8d-5730-4559-8f2e-8f07b7eda52c

Device Description

Finger Plethysmograph (Models TS3 and TS4)

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
DRN	Device, counter-pulsating, external	Cardiovascular	870.5225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62331	Plethysmography phototransducer	A photoelectric sensor designed to be applied externally to a body area (e.g., limb, fingertip, toe, sacral region) for the transcutaneous measurement of blood volume changes using light detection. It is intended to be connected to a parent device (e.g., limb plethysmograph, pressure ulcer risk assessment analyser) whereby volume changes are displayed graphically to represent blood flow/pulse, typically for vascular function assessment in a limb [e.g., measurement of toe brachial pressure index], or to assess a patient’s risk of developing pressure ulcers. Although similar to a pulse oximeter probe it is not capable of oxygen saturation measurements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817980021198	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K033617	000