FDA.reportPublic FDA data

moorVMS-TREND PC Software

Primary DI
15060484490164
Brand
moorVMS-TREND PC Software
Company
MOOR INSTRUMENTS LIMITED
Model
1
Device description
moorVMS-TREND PC software is intended for use with moorVMS-LDF and moorVMS-OXY, for long term blood flow and tissue oxygen trend monitoring. It is intended for a variety of physiological and clinical research applications in clinical settings. The clinical value of measurements in disease states has not been established. The moorVMS-TREND is not intended to be used as the sole basis for diagnosis or therapy. The moorVMS-TREND Software is not intended for critical care monitoring where loss of function could result in harm to the patient.
Published
2019-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083082000
K112826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083082000MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORSMoor Instruments, Ltd.2009-01-13GEX
K112826000NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITORMoor Instruments, Ltd.2012-10-10MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060484490164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506048449016415060484490164

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeterA mains electricity (AC-powered) photoelectric device that noninvasively calculates 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. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+44129735715service@moor.co.uk

Regulatory Flags#

DUNS number
398037580
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060484490157moorFLPI-2 Clinical PC Software12018-12-13
15060484490133Moor Instruments LtdNON-STERILE LASER DOPPLER PROBES2018-12-13
15060484490140Moor Instruments LtdNON-STERILE OXYGENATION AND LASER DOPPLER COMBINED2018-12-13
15060484490003Moor Instruments LtdmoorVMS-LDF2016-07-08
15060484490010Moor Instruments LtdmoorVMS-PRES2016-07-08
15060484490027Moor Instruments LtdmoorVMS-OXY2016-07-08
15060484490034Moor Instruments LtdmoorFLPI2016-07-08
15060484490041Moor Instruments LtdmoorFLPI22016-07-08
15060484490058Moor Instruments LtdmoorLDI22016-07-08
15060484490065Moor Instruments LtdmoorLDLS2016-07-08
15060484490072Moor Instruments LtdmoorLDI2-BI2016-07-08
15060484490089Moor Instruments LtdmoorLDLS-BI2016-07-08
15060484490096moorVMS-PC Software42016-11-24
15060484490102moorVMS-VASC PC Software22016-11-24
15060484490119moorFLPI-2 Review PC Software52016-11-29
15060484490126moorFLPI2- Measurement PC Software22016-11-29

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