FDA.reportPublic FDA data

Intra.Ox Optical QC Target

Primary DI
B426OXY2QCT10
Brand
Intra.Ox Optical QC Target
Company
VIOPTIX, INC.
Model
OXY2-QCT-1
Catalog number
OXY-2-QCT-1
Published
2020-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191676000Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc.2019-09-16MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B426OXY2QCT10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeter sensor, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
127211923
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B426OXY2DUR10Intra.Ox Smart SensorOXY2-DUR-1OXY-2-DUR-12020-04-17
B426OXY2STH10Intra.Ox Disposable SheathOXY2-STH-1OXY-2-STH-12020-04-17
B426OXY2SPD10T.Ox SP SensorOXY-2-SPD-1OXY-2-SPD-12016-09-26
B426OXY2SPI10T.Ox SS SensorOXY2-SPI-1OXY-2-SPI-12016-09-26

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