FDA.reportPublic FDA data

Spacelabs Healthcare

Primary DI
10841522129117
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
91449
Catalog number
91449
Device description
DESKTOP 50MM PRINTER
Published
2021-05-07
Public version status
New
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
DSFRECORDER, PAPER CHART

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSFRecorder, Paper ChartCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522129117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152212911710841522129117

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, printingA small unit dedicated to providing a print-out of patient related data, e.g., an electrocardiogram (ECG), blood pressure, haemoglobin oxygen saturation (SpO2). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer providing the information requested for the print-outs from this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
08428763008309PAQ. 80x90x280/QT-HS75/ GE MAC400AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008330PAQ.90X70X400*31*OTE.P-80.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008347PAQ.90X90X400*31*SCH.AT1.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008354PAQ.90X90X200*31*SCH.AT4.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008361PAQ.90X90X360*28*MICROSMART.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008385PAQ.90X90X360.MICROSMART.(MX)AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008392PAQ.90X90X130/QT-HS/ZOLLAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008415PAQ.104X100X300*31*CRDT-31.MNAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008439PAQ.106X140X200*31*BURD7971MNAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008446PAQ.108X140X200.ELI-150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008453PAQ.110X100X300*31*NK.BL.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008460PAQ.110X150X300*31*FQW1103150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008477PAQ.110X100X200*31*BIOSET3700AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008484PAQ.110X140X150.FQW110-2-140AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008491PAQ.110X150X200.FQW110-3-150AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008507PAQ.110X140X150.FQW1102140.MMAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008514PAQ.110X140X100.FUKUDA FX7202AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008521PAQ.110X150X300.MEDTRONIC9790AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008538PAQ.110X100X150.BIOSET 3700AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008545PAQ. 110x140x140/QT-HS/ FX7202AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008552PAQ.110X140X150.GE.MAC800AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008569PAQ.110X140X140/QT-HS/OEM BEXEN XEG114AAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008583PAQ.111X100X200.ORIONAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008590PAQ.112X100X300*31*DELTA3.MN.AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008613PAQ.112X90X300.SUZ-KENZAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008637PAQ.112X100X300/QI-HS/GOLDWAYAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008644PAQ.112X90X160.CADENCEAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008651PAQ.112X100X100.SRF618BAB MEDICA GROUP, S.A.DSF2025-07-28
08428763008668PAQ.112X100X300.ELAN1100AB MEDICA GROUP, S.A.DSF2025-07-28
08428763008675PAQ.112X90X150.CADENCEAB MEDICA GROUP, S.A.DSF2025-07-28