moorFLPI-2 Clinical PC Software

Primary DI
15060484490157
Brand
moorFLPI-2 Clinical PC Software
Company
MOOR INSTRUMENTS LIMITED
Model
1
Device description
moorFLPI-2 Clinical PC Software V1
Published
2018-12-13
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122943000MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.2013-01-03DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060484490157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506048449015715060484490157

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.

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
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
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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Primary DI, Brand, Company table
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00643169630635Bio-Probe™MEDTRONIC, INC.DPT2017-01-22
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10351688508669MedexICU MEDICAL, INC.DPT2016-12-30
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10351688503060MedexICU MEDICAL, INC.DPT2016-12-29
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50351688505741MedexICU MEDICAL, INC.DPT2016-12-29
10351688503008MedexICU MEDICAL, INC.DPT2016-12-13
50351688503006MedexICU MEDICAL, INC.DPT2016-12-13
10351688503619MedexICU MEDICAL, INC.DPT2016-12-07
10351688503671MedexICU MEDICAL, INC.DPT2016-12-07
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10351688503794MedexICU MEDICAL, INC.DPT2016-12-07
50351688503792MedexICU MEDICAL, INC.DPT2016-12-07
15060484490119moorFLPI-2 Review PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
15060484490126moorFLPI2- Measurement PC SoftwareMOOR INSTRUMENTS LIMITEDDPT2016-11-29
10351688508416MedexICU MEDICAL, INC.DPT2016-10-19
10351688508423MedexICU MEDICAL, INC.DPT2016-10-19
10351688508560MedexICU MEDICAL, INC.DPT2016-10-19
10351688508775MedexICU MEDICAL, INC.DPT2016-10-19
10351688508782MedexICU MEDICAL, INC.DPT2016-10-19
10351688508805MedexICU MEDICAL, INC.DPT2016-10-19