FDA.reportPublic FDA data

Spacelabs Healthcare

Primary DI
10841522120206
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
96280
Catalog number
040-0441-02
Device description
KIT,DUAL ANTENNA,PASSIVE,UHF,PLENUM,ROHS
Published
2017-01-03
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
DSIDETECTOR AND ALARM, ARRHYTHMIA
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
MLDMONITOR, ST SEGMENT WITH ALARM
MSXSYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141156000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141156000SPACELABS HEALTHCARE TELEMETRY RECEIVERSpacelabs Healthcare2014-09-09MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522120206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152212020610841522120206

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography monitoring system receiverAn electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522130298Eclipse ProEclipse Pro712-1052-012023-02-23
10841522100406Spacelabs HealthcareAbsorber122009022016-12-29
10841522100413Spacelabs HealthcareAbsorber122009032016-12-29
10841522128769Eclipse MiniEclipse Mini989002024-03-15
10841522128851Eclipse ProEclipse Pro987002023-10-09
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
00198953009567Carescape ONEGE Healthcare Finland OyMLD2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDSI2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
06944413835153Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612161049FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612209543FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226113FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226922FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612228070FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612230370FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612230387FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.DSI2026-07-17