T.Ox SP Sensor

Basic Information

• Brand Name: T.Ox SP Sensor
• Primary DI: B426OXY2SPD10
• Version / Model: OXY-2-SPD-1
• Catalog Number: OXY-2-SPD-1
• Company Name: VIOPTIX, INC.
• Labeler DUNS: 127211923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a796a55d-721b-42b9-8218-4224b472d299

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46618	Tissue saturation oximeter sensor, single-use	A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B426OXY2SPD10	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042657	000
K141234	000