AccessGUDID - DEVICE: Spectros T-Stat (00851136007056)

GUDID

Device Identifier (DI) Information

Brand Name: Spectros T-Stat
Version or Model: T-Stat 303
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T-Stat 303
Company Name: SPECTROS CORPORATION

Primary DI Number: 00851136007056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929856680 *Terms of Use

Device Description: The T-Stat 303 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 hemoglobin oxygen saturation of blood in microvascular tissue spaces.

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUD	Oximeter, Tissue Saturation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081233	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: 66164231-8f8b-4be1-af54-95e3ba1d0de9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 03, 2016