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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522106712Spacelabs HealthcareDATUM130112182017-01-03
10841522131639Eclipse MiniEclipse Mini98900-UK2025-09-29
10841522131417Spacelabs HealthcarePatient cables & ECG leadwires700-0328-012025-09-03
10841522131424Spacelabs HealthcarePatient cables & ECG leadwires700-0330-012025-09-03
10841522129599SpacelabsABP Cuffs and Cuff Covers015-0068-07Q2025-03-13
10841522130816TrulinkNIBP Hoses and Adapters714-0060-022025-03-13
10841522131431OnTrakOnTrak90227-82025-02-27
10841522100406Spacelabs HealthcareAbsorber122009022016-12-29
10841522100413Spacelabs HealthcareAbsorber122009032016-12-29
10841522100383Spacelabs HealthcareAbsorber122009002016-12-29
10841522100390Spacelabs HealthcareAbsorber122009012016-12-29
10841522100420Spacelabs HealthcareAbsorber122009042016-12-29
10841522100437Spacelabs HealthcareAbsorber122009052016-12-29
10841522131455QubeQube Compact Monitor913902024-12-04
10841522131462qube miniQube Mini913892024-12-04
10841522131479XprezzonXprezzon Monitor913932024-12-04
10841522129216SpacelabsSmart Alarm Interface (SAI)961812024-08-16
30841522126417TrulinkNIBP Hoses and adapters704-00272024-07-16
10841522129773Lifescreen ProLifescreen Pro040-5173-002024-07-16
30841522125618Spacelabs HealthcarePatient cables & ECG leadwires50-00492018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17540262100143Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-03-09
17540262110142Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-03-09
17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-03-09
06944413849570Holter ECG and ABP SystemEdan Instruments, Inc.DQK2026-03-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00851424007089VIVOCatheter Precision, Inc.DQK2026-02-03
00085142400710VIVO Positioning PatchesCatheter Precision, Inc.DQK2026-02-03
00851424007119VIVO SystemCatheter Precision, Inc.DQK2026-02-03
05415067055613EnSite™ST. JUDE MEDICAL, INC.DQK2026-01-08
05415067054883EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-19
00732094360295Welch Allyn, Inc.WELCH ALLYN, INC.DQK2025-12-18
05415067053435EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067053503EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067053510EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054968EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054975EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054982EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054999EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055217EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055224EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055231EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055248EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
00850012226291iMap 3D Mapping and Navigation SystemCardionxt IncDQK2025-12-10
05415067051219EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
05415067051288EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
03770019196069Volta AF-Xplorer IISUBSTRATE HDDQK2025-11-18
00763000998394N/AMEDTRONIC, INC.DQK2025-11-14
05415067051158EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15
05415067051172EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15