FDA.reportPublic FDA data

Spacelabs Healthcare

Primary DI
10841522113116
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
93300
Catalog number
93300
Device description
ELANCE VITAL SIGNS MONITOR
Published
2016-12-28
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
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093501000ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONSpacelabs Medical, Inc.2009-11-24MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522113116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152211311610841522113116

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software; typically it incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522105067UltraliteUltralite90217A-12016-10-21
10841522103292Spacelabs Healthcare98400N/A2016-09-23
10841522125102PathfinderSLPathfinder SL040-1757-002018-06-19
10841522128851Eclipse ProEclipse Pro987002023-10-09
10841522100208Spacelabs Healthcare90499904992016-10-10
10841522118173Spacelabs HealthcareDATUM130132232017-01-03
10841522118258Spacelabs HealthcareDATUM130222572017-01-03
10841522118265Spacelabs HealthcareDATUM130232182017-01-03
10841522118326Spacelabs HealthcareDATUM130612182017-01-03
10841522118357Spacelabs HealthcareDATUM130622182017-01-03
10841522118371Spacelabs HealthcareDATUM130622522017-01-03
10841522118401Spacelabs HealthcareDATUM130632182017-01-03
10841522118494Spacelabs HealthcareDATUM130121182016-12-29
10841522118562Spacelabs HealthcareDATUM130131182016-12-29
10841522118579Spacelabs HealthcareDATUM130131292016-12-29
10841522118593Spacelabs HealthcareDATUM130211182016-12-29
10841522118616Spacelabs HealthcareDATUM130221182016-12-29
10841522118685Spacelabs HealthcareDATUM130611182016-12-29
10841522118722Spacelabs HealthcareDATUM130613302016-12-29
10841522118753Spacelabs HealthcareDATUM130621182016-12-29

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Primary DI, Brand, Company table
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00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
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B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
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