Spectros T-Stat

GUDID 10851136007046

Tissue saturation oximeter sensor, single-use

Primary Device ID	10851136007046
NIH Device Record Key	d8e9abd4-8d49-4cf8-91b3-7c9bc4d9510c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spectros T-Stat
Version Model Number	CTH-060-ORA M
Company DUNS	929856680
Company Name	SPECTROS CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	650-851-4040
Email	info@spectros.com

Device Issuing Agency	Device ID
GS1	00851136007049 [Primary]
GS1	10851136007046 [Package] Contains: 00851136007049 Package: Box [5 Units] In Commercial Distribution

MUD	Oximeter, Tissue Saturation

Steralize Prior To Use	false
Device Is Sterile	true

00851136007056	The T-Stat 303 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized
10851136007046	Oral sensor for use with the T-Stat Monitor to measure ischemia
10851136007039	Gastrointestinal sensor for use with the T-Stat monitor to measure ischemia in colorectal tissue
00851136007025	Endoscopic sensor for use with the T-Stat Monitor to measure ischemia
10851136007015	1 cm diameter surface sensor for use with the T-Stat Monitor to measure ischemia.
10851136007008	2.5 cm diameter surface probe for use with the T-Stat Monitor to measure ischemia.
00851136007063	The T-Stat 2.0 Microvascular Tissue Oximeter provides a continuous, non-invasive, and localized