FDA.reportPublic FDA data

Pathfinder

Primary DI
10841522125645
Brand
Pathfinder
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
98000, 98200
Catalog number
040-1726-01
Device description
PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
Published
2018-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522125645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152212564510841522125645

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyserAn electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522100406Spacelabs HealthcareAbsorber122009022016-12-29
10841522100413Spacelabs HealthcareAbsorber122009032016-12-29
10841522128769Eclipse MiniEclipse Mini989002024-03-15
10841522128851Eclipse ProEclipse Pro987002023-10-09
10841522130298Eclipse ProEclipse Pro712-1052-012023-02-23
10841522123122TrulinkAdapter Cables700-0290-002017-09-25
10841522128790SPACELABS HEALTHCARE9022790227-182023-05-25
10841522105067UltraliteUltralite90217A-12016-10-21
10841522126857SPACELABS HEALTHCAREUltralite90217A-22019-02-28
10841522123177ABP9022790227-12017-09-15
10841522126864SPACELABS HEALTHCARE9022790227-22019-02-28
10841522131417Spacelabs HealthcarePatient cables & ECG leadwires700-0328-012025-09-03
10841522131424Spacelabs HealthcarePatient cables & ECG leadwires700-0330-012025-09-03
10841522125478Spacelabs HealthcarePatient cables & ECG leadwires50-00492018-08-10
10841522131479XprezzonXprezzon Monitor913932024-12-04
10841522131455QubeQube Compact Monitor913902024-12-04
10841522106439Ultraview SLUltraview SL®91496-U2016-10-07
10841522103292Spacelabs Healthcare98400N/A2016-09-23
10841522125102PathfinderSLPathfinder SL040-1757-002018-06-19
10841522100208Spacelabs Healthcare90499904992016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DXH2026-07-16
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQK2026-02-24
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11