Spectros T-Stat T-Stat 2.0

GUDID 00851136007063

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.

SPECTROS CORPORATION

Tissue saturation oximeter

• Primary Device ID: 00851136007063
• NIH Device Record Key: ff4f772c-e8d6-41db-a953-df251f8bc07e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectros T-Stat
• Version Model Number: T-Stat 2.0
• Catalog Number: T-Stat 2.0
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851136007063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192322

FDA Product Code

• MUD: Oximeter, Tissue Saturation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [Spectros T-Stat]

• 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