Intra.Ox Disposable Sheath OXY-2-STH-1

GUDID B426OXY2STH10

VIOPTIX, INC.

Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use Tissue saturation oximeter sensor, single-use

• Primary Device ID: B426OXY2STH10
• NIH Device Record Key: e3a5997d-6909-4d00-abf6-4f502eb43225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intra.Ox Disposable Sheath
• Version Model Number: OXY2-STH-1
• Catalog Number: OXY-2-STH-1
• Company DUNS: 127211923
• Company Name: VIOPTIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B426OXY2STH10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191676

FDA Product Code

• MUD: Oximeter, Tissue Saturation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-04-17

Devices Manufactured by VIOPTIX, INC.

• B426OXY2DUR10 - Intra.Ox Smart Sensor: 2020-04-27
• B426OXY2QCT10 - Intra.Ox Optical QC Target: 2020-04-27
• B426OXY2STH10 - Intra.Ox Disposable Sheath: 2020-04-27
• B426OXY2STH10 - Intra.Ox Disposable Sheath: 2020-04-27
• B426OXY2SPD10 - T.Ox SP Sensor: 2018-07-06
• B426OXY2SPI10 - T.Ox SS Sensor: 2018-07-06