FDA.reportPublic FDA data

Spacelabs Healthcare

Primary DI
10841522107825
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
94830
Device description
Fetal Intra-Partum Monitor
Published
2017-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CBSANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522107825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210782510841522107825

GMDN Terms#

Term, Definition table
TermDefinition
Foetal cardiac monitorA mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. Typically foetal heart rate is measured, but heart valve movement can also be assessed. The device operates noninvasively by: 1) electronically registering and graphically presenting foetal heart sounds; 2) discriminating foetal and maternal electrocardiographic signals obtained from the maternal abdomen with external electrodes; or 3) transmitting and receiving ultrasonic energy into and from the pregnant woman usually by means of continuous wave (Doppler) echoscopy. The device may include an alarm that signals when the heart rate crosses a pre-set threshold.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
145581588
Device count
1
Premarket exempt
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCBS2026-04-15
04571501890019RIKEN KEIKI Co.,Ltd.RIKEN KEIKI CO.,LTD.CBS2025-03-26
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2024-12-19
06944413815889Patient MonitorEdan Instruments, Inc.CBS2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.CBS2024-06-17
06944413815902Patient MonitorEdan Instruments, Inc.CBS2024-06-17
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBS2024-05-13
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCBS2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCBS2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCBS2023-04-19
00195278524089NAGE Healthcare Finland OyCBS2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCBS2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCBS2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCBS2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682104135NAGE Healthcare Finland OyCBS2022-03-07
00840682104302NAGE Healthcare Finland OyCBS2022-03-07
00840682141291B1X5 Software UpgradeGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-18
00840682138574NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-16
00840682138581NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-16
B510PM2000M1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000TM1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XL1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XLPLUS1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XLPRO1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16