Intra.Ox Disposable Sheath

Basic Information

• Brand Name: Intra.Ox Disposable Sheath
• Primary DI: B426OXY2STH10
• Version / Model: OXY2-STH-1
• Catalog Number: OXY-2-STH-1
• Company Name: VIOPTIX, INC.
• Labeler DUNS: 127211923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-17
• Public Version: 2
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: e3a5997d-6909-4d00-abf6-4f502eb43225

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
46618	Tissue saturation oximeter sensor, single-use	A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement 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. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B426OXY2STH10	HIBCC