FDA.reportPublic FDA data

CareStation Server

Primary DI
00840241600269
Brand
CareStation Server
Company
Kestra Medical Technologies, Inc.
Model
80433-002
Catalog number
80433-002
Device description
CareStation Server acquires and displays data from the WCD for clinicians to view.
Published
2022-06-10
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
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840241600269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840241600269008402416002698402416002690840241600269

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060944361
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840241600375ASSURE WCD System80014-00380014-0032026-04-15
00840241600405ASSURE, Monitor80008-00580008-0052026-04-15
00840241600412Kestra Provided Device Patient Application80740-01080740-0102026-02-04
00840241600399Kestra Provided Device Patient Application80740-00580740-0052025-04-30
00840241600382Kestra Provided Device Patient Application80740-00180740-0012024-09-18
00840241600313ASSURE Wearable ECG80553-00180553-0012024-09-18
00840241600320Battery 80499-00380499-0032024-09-18
00840241600337System Cable80500-00380500-0032024-09-18
00840241600344ASSURE Assist Service80739-00180739-0012024-09-18
00840241600238ASSURE WCD System80014-00280014-0022023-06-26
00840241600283ASSURE Patient Application80601-001 80601-001 2023-03-13
00840241600306CareStation Server80605-00480605-0042023-03-12
00840241600290CareStation Server80605-00380605-0032023-02-12
00840241600276CareStation Server80433-00380433-0032023-02-10
00840241600221ASSURE, Monitor80008-00480008-0042022-12-09
00840241600245ASSURE, Tablet80041-00280041-0022022-12-09
00840241600252ASSURE Patient Application80429-00380429-0032022-06-24
00840241600009ASSURE, Battery 3322882-0053322882-0052021-11-15
00840241600016ASSURE, Charger3326633-0043326633-0042021-11-15
00840241600023ASSURE, Therapy Cable80004-00380004-0032021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28