FDA.reportPublic FDA data

Moor Instruments Ltd

Primary DI
15060484490140
Brand
Moor Instruments Ltd
Company
MOOR INSTRUMENTS LIMITED
Model
NON-STERILE OXYGENATION AND LASER DOPPLER COMBINED
Device description
Non-sterile Oxygenation, and Laser Doppler combined Probes
Published
2018-12-13
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
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112826000NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITORMoor Instruments, Ltd.2012-10-10MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060484490140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506048449014015060484490140

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
DM exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00690103219616ForeSight IQEdwards Lifesciences LLCMUD2025-07-11
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00690103217728HemoSphereEdwards Lifesciences LLCMUD2025-07-11
10884521845985INVOSCovidien LPMUD2025-07-03
00690103217957HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
10884521845039INVOSCovidien LPMUD2025-02-08
20884521845036INVOSCovidien LPMUD2025-02-08
00690103218879HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103211313ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211320ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211337ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211318ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211332ForeSightEdwards Lifesciences LLCMUD2024-08-26
10884521701243INVOSCovidien LPMUD2024-04-14
10884521557048INVOSCovidien LPMUD2024-04-14
B376KD2050SnapshotNIRKent Imaging IncMUD2024-04-05
00690103217124HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218848HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218862HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
10884521824409INVOSCovidien LPMUD2023-11-03
10884521824416INVOSCovidien LPMUD2023-11-03