Spectros T-Stat

Basic Information

• Brand Name: Spectros T-Stat
• Primary DI: 00851136007063
• Version / Model: T-Stat 2.0
• Catalog Number: T-Stat 2.0
• Company Name: SPECTROS CORPORATION
• Labeler DUNS: 929856680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 1
• Public Version Date: 2019-10-29
• Public Version Status: New
• Public Device Record Key: ff4f772c-e8d6-41db-a953-df251f8bc07e

Device Description

The T-Stat 2.0 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized measurement of the microvascular hemoglobin oxygen saturation. sensitive to regional and global reduced flow or no-flow ischemia. It is intended for use as an adjunct monitor of the localized oxygen saturation of blood in microvasular tissue spaces.

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
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46615	Tissue saturation oximeter	A mains electricity (AC-powered) photoelectric device that noninvasively calculates 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. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851136007063	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192322	000