FDA.reportPublic FDA data

Intesys Clinical Suite

Primary DI
10841522100185
Brand
Intesys Clinical Suite
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
92881
Catalog number
V5.2.3
Device description
PRINT MANAGER,92881
Published
2017-06-26
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
DSFRECORDER, PAPER CHART

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522100185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210018510841522100185

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Storage And Handling#

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

Regulatory Flags#

DUNS number
145581588
Device count
1
Premarket exempt
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
10192253055931KendallCardinal Health 200, LLCDSF2026-06-19
10192253055955KendallCardinal Health 200, LLCDSF2026-06-19
20192253055884KendallCardinal Health 200, LLCDSF2026-06-19
00884838120358Thermal Printer Kit, USBPhilips Medizin Systeme Böblingen GmbHDSF2026-06-04
08428763001751ROLLO 57X15X12E/GR60/MICROTR.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001768ROLLO 57X15X12E/GR60/SPIRO501AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001775ROLLO 57X25X12E.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001782ROLLO 57X15X12E.MATACHANAAB MEDICA GROUP, S.A.DSF2025-11-12
08428763001805ROLLO 57X40X12E.PRINTER.AB MEDICA GROUP, S.A.DSF2025-11-12
08428763001812ROLLO 58X8X12E/GR60.PRINTERAB MEDICA GROUP, S.A.DSF2025-11-12
08428763007593PAQ.112X100X100BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008712PAQ.112X150X300.HEARTSCREEN CLINICAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008729PAQ.112X100X160.BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008736PAQ.112X90X160.CADENCE M50-78019AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008743PAQ.112X90X300.CARDICO-601AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008750PAQ.112X100X100BIOCAREAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008767PAQ.114X100X150.FETATRACK310AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008774PAQ.114X70X250/QT-75HS/WELCH ALLYN CP-5AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008798PAQ.120X100X150*31*CTG.FHR240AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008811PAQ.120X100X150*31*CTG.FHR200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008859PAQ.120X100X300.K360/AR1200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008866PAQ.120X150X250.ERGOCID.ATAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008873PAQ.120X100X300.AR1200AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008880PAQ.120x150x300 SPACELABS 90469AB MEDICA GROUP, S.A.DSF2025-11-12
08428763008897PAQ. 120x100x(2x150) AR1200-OEM ET MEDIAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008927PAQ.126X150X170*31*OTE-120.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008941PAQ.126X150X150*31*OTE-120.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763008989PAQ.134X100X300*31*DELTA-3.MNAB MEDICA GROUP, S.A.DSF2025-11-12
08428763009009PAQ.135X140X150*31*SCH.AT5AB MEDICA GROUP, S.A.DSF2025-11-12
08428763009030PAQ.143X150X300*31*SONICAIDAB MEDICA GROUP, S.A.DSF2025-11-12