FDA.reportPublic FDA data

IntelliVue GuardianSoftware

Primary DI
00884838081925
Brand
IntelliVue GuardianSoftware
Company
Philips Medizin Systeme Böblingen GmbH
Model
IntelliVue GuardianSoftware
Catalog number
866009
Device description
IntelliVue GuardianSoftware is a software-only product. It is the core of the Guardian General Care Solution, which provides fully customizable workflow support for automated vital signs taking, early warning scoring, patient deteroration detection, caregiver notification and care escalation for medical/surgical care, ED waiting/triage and other general care areas. It also mediates the data flow between the devices and hospital systems. Guardian Software license options listed enable desired features and capabilities for specified number of patients, clients, selected measurement technologies as well as required connectivity to hospital systems.
Published
2016-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151736000Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015-10-21DXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838081925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838081925008848380819258848380819250884838081925

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

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
314101143
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838119017Telemetry AccessoriesECG 3 lead Grabber, AAMI + SpO2, Tele9898031718112026-05-28
00884838119024Telemetry AccessoriesECG 5 lead Snaps, AAMI, Tele9898031718212026-05-28
00884838119031Telemetry AccessoriesECG 5 lead Grabber, AAMI, Tele9898031718312026-05-28
00884838119048Telemetry AccessoriesECG 5 lead Snaps, AAMI + SpO2, Tele9898031718412026-05-28
00884838119055Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2, Tele9898031718512026-05-28
00884838119062Telemetry AccessoriesECG 6 lead Grabber, AAMI, Tele9898031718612026-05-28
00884838119185Telemetry AccessoriesTelemetry Adapter 5-Lead + Masimo SpO29898032023812026-05-28
00884838119192Telemetry AccessoriesTelemetry Adapter Masimo SpO2-only9898032023912026-05-28
00884838119208Telemetry AccessoriesECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112026-05-28
00884838119215Telemetry AccessoriesECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212026-05-28
00884838119222Telemetry AccessoriesTelemetry Adapter 6-Lead + Masimo SpO29898032042912026-05-28
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
00884838119109Telemetry AccessoriesECG 5 lead Grabber, IEC + SpO2, Tele9898031719512026-05-26
00884838119116Telemetry AccessoriesECG 6 lead Grabber, IEC, Tele9898031719612026-05-26
00884838119123Telemetry AccessoriesECG 6 lead Grabber, IEC + SpO2, Tele9898031719712026-05-26
00884838119130Telemetry AccessoriesECG Trunk Cable AAMI/IEC9898031722212026-05-26
00884838119147Telemetry AccessoriesTelemetry Adapter 6L+SpO29898031990712026-05-26
00884838119154Telemetry AccessoriesTelemetry Adapter SpO2-only9898031990812026-05-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXJ2026-02-11
05415334053458BarcoBarco NVDXJ2025-06-04
05415334053472BarcoBarco NVDXJ2025-06-04
05415334053663BarcoBarco NVDXJ2025-06-04
05415334053670BarcoBarco NVDXJ2025-06-04
10889483575710Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575734Vital Signs™AirLife Finland OyDXJ2025-03-31
10889483575772Vital Signs™AirLife Finland OyDXJ2025-03-31
05415334050815Nexxis ORBarco NVDXJ2024-02-22
05415334050822Nexxis ORBarco NVDXJ2024-02-22
05415334050839Nexxis ORBarco NVDXJ2024-02-22
10193489385625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
40193489385626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
05415334037625Nexxis ORBarco NVDXJ2023-05-25
05415334037632Nexxis ORBarco NVDXJ2023-05-25
05415334037687Nexxis ORBarco NVDXJ2023-05-25
05415334042346Nexxis ORBarco NVDXJ2023-05-25
06970438060003BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
06970438060065BIGTIDEShenyang Torch-Bigtide Digital Technology Co., Ltd.DXJ2022-09-05
05415334039124Nexxis ORBarco NVDXJ2022-07-11
05415334039131Nexxis ORBarco NVDXJ2022-07-11
10884450568658High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-31
20884450387669High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-15
10884450569334Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-03-05
20884450387676High Pressure Tubing, Keep™Merit Medical Systems, Inc.DXJ2022-03-04
20884450569720Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-03-04
10884450569297Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-02-28
20884450569317Pressure Monitor TubingMerit Medical Systems, Inc.DXJ2022-02-28