FDA.reportPublic FDA data

Spacelabs Healthcare

Primary DI
10841522129506
Brand
Spacelabs Healthcare
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
98200
Catalog number
040-5172-00
Device description
SENTINEL V11.X UPGRADE
Published
2021-05-03
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
DQKComputer, diagnostic, programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522129506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152212950610841522129506

GMDN Terms#

Term, Definition table
TermDefinition
Cardiology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145581588
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
17540262100143Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-03-09
17540262110142Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-03-09
17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-03-09
06944413849570Holter ECG and ABP SystemEdan Instruments, Inc.DQK2026-03-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00851424007089VIVOCatheter Precision, Inc.DQK2026-02-03
00085142400710VIVO Positioning PatchesCatheter Precision, Inc.DQK2026-02-03
00851424007119VIVO SystemCatheter Precision, Inc.DQK2026-02-03
05415067055613EnSite™ST. JUDE MEDICAL, INC.DQK2026-01-08
05415067054883EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-19
00732094360295Welch Allyn, Inc.WELCH ALLYN, INC.DQK2025-12-18
05415067053435EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067053503EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067053510EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054968EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054975EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054982EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054999EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055217EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055224EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055231EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055248EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
00850012226291iMap 3D Mapping and Navigation SystemCardionxt IncDQK2025-12-10
05415067051219EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
05415067051288EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
03770019196069Volta AF-Xplorer IISUBSTRATE HDDQK2025-11-18
00763000998394N/AMEDTRONIC, INC.DQK2025-11-14
05415067051158EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15
05415067051172EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15