FDA.reportPublic FDA data

IntelliSpace Console

Primary DI
00884838084674
Brand
IntelliSpace Console
Company
Philips Medical Systems Hsg
Model
Clinical Analytics Platform - Engine
Catalog number
867138
Device description
Clinical Information System
Published
2019-03-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXJDisplay, Cathode-Ray Tube, Medical
NSXSoftware, transmission and storage, patient data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2
NSXSoftware, transmission and storage, patient data

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151366000Philips CS770 IntelliSpace Critical Care and AnesthesiaPhilips Medical Systems2015-10-30DXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838084674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838084674008848380846748848380846740884838084674

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
790605856
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12
00884838014978NOUNLong Complete Lead Set AAMI9898031516512017-01-26
00884838014985NOUNPW CBL Long Complete Lead Set IEC9898031516612017-01-04
00884838014992NOUNTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712017-11-08
00884838015005NOUNTC ADDITIONAL LONG LEADS KIT: IEC9898031517812017-04-28
00884838025479NOUNPW TC20 10-Lead Patient Cable IEC9898031758912016-10-06
00884838025486NOUNPW TC20 10-Lead Patient Cable AHA9898031759012016-11-23
00884838025493NOUNPW TC20 Long 10-Lead Patient Cable IEC9898031759112016-11-03
00884838025509NOUNPW TC20 Long 10-Lead Patient Cable AHA9898031759212016-10-06
00884838029118NOUN12L Leadset, Grabber, AAMI9898031801212016-12-19
00884838029125NOUN12L Leadset, Grabber, IEC9898031801312016-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334062412Nexxis ORBarco NVDXJ2026-04-28
04251303302278CuratOREIZO GmbHDXJ2026-03-02
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
18033737712341THD Procto Software SystemTHD SPANSX2022-10-07
58051887042642THD Procto Software SystemTHD SPANSX2022-10-07
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