FDA.reportPublic FDA data

Moor Instruments Ltd

Primary DI
15060484490089
Brand
Moor Instruments Ltd
Company
MOOR INSTRUMENTS LIMITED
Model
moorLDLS-BI
Device description
moorLDLS-BI - Laser Doppler Line Scanner, Burns Imaging System
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPTProbe, Blood-Flow, Extravascular
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132163000MOORLDLS-BI LASER DOPPLER BURNS IMAGERMoor Instruments, Ltd.2014-01-29DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060484490089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506048449008915060484490089

GMDN Terms#

Term, Definition table
TermDefinition
Cutaneous microcirculation laser Doppler imaging deviceA mobile, mains electricity (AC-powered) device designed to use the laser Doppler imaging (LDI) technique of skin blood flow to visualize the perfusion of cutaneous microcirculation over a surface area. It typically consists of a dedicated camera system which includes a laser, an imaging sensor and electronics, mounted on a wheeled pedestal. The device works by non-invasively detecting the frequency change of the laser radiation reflected by the moving red blood cells in the small vessels. It is used in pre-, intra- [in the operating room (OR)], and postoperative clinical assessment, typically to evaluate burn wound healing potential, or for assessing reperfusion of cutaneous flaps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity45 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
398037580
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060484490157moorFLPI-2 Clinical PC Software12018-12-13
15060484490164moorVMS-TREND PC Software12019-10-31
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
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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