FDA.reportPublic FDA data

LATITUDE® Clarity

Primary DI
00802526613838
Brand
LATITUDE® Clarity
Company
BOSTON SCIENTIFIC CORPORATION
Model
7260
Catalog number
7260
Device description
Device Services Software
Published
2020-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MXDRecorder, event, implantable cardiac, (with arrhythmia detection)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193473000LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - USBoston Scientific Corporation2020-06-26MXD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526613838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526613838008025266138388025266138380802526613838

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106295384
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055095Assert-IQ™ST. JUDE MEDICAL, INC.MXD2026-01-05
05415067053275Merlin.net™ST. JUDE MEDICAL, INC.MXD2025-10-21
00802526618208myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2025-04-11
00802526618215myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2025-04-11
00802526625404LUX-Dx™BOSTON SCIENTIFIC CORPORATIONMXD2024-09-30
00763000754914CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) ApplicationMEDTRONIC, INC.MXD2024-04-25
00763000891091CareLink SmartSync™ LINQ II™ Platform ApplicationMEDTRONIC, INC.MXD2024-04-25
00802526621017LUX-Dx™ Clinic Assistant Mobile DeviceBOSTON SCIENTIFIC CORPORATIONMXD2023-12-14
00763000613747LINQ II™MEDTRONIC, INC.MXD2023-11-19
00802526621000myLUX™ Mobile DeviceBOSTON SCIENTIFIC CORPORATIONMXD2023-09-08
00802526620706LUX-Dx II+™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526620713LUX-Dx II™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526621307myLUX™BOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526623103myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
00802526623110myLUX™ Patient AppBOSTON SCIENTIFIC CORPORATIONMXD2023-08-31
04035479177850BioMonitor IVBIOTRONIK SE & Co. KGMXD2023-05-24
00763000504519AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000504526AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000504533AccuRhythm™ AIMEDTRONIC, INC.MXD2021-12-31
00763000562625Reveal LINQ™MEDTRONIC, INC.MXD2021-09-04
00763000562632Reveal LINQ™MEDTRONIC, INC.MXD2021-09-04
00763000554002LINQ II™MEDTRONIC, INC.MXD2021-06-14
00763000060374LINQ II™MEDTRONIC, INC.MXD2020-07-18
00763000162191LINQ II™MEDTRONIC, INC.MXD2020-07-18
00802526607103LUX-Dx™ Insertable Cardiac MonitorBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607363myLUX™ Patient Kit with mobile deviceBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607370LUX-Dx™ Clinic Assistant Kit with mobile deviceBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607608myLUX™ patient appBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
00802526607615LUX-Dx™ Clinic Assistant appBOSTON SCIENTIFIC CORPORATIONMXD2020-07-01
04035479169862BioMonitor IIImBIOTRONIK SE & Co. KGMXD2020-05-06