FDA.reportPublic FDA data

Cardiopulonary Corp.

Primary DI
00854709006074
Brand
Cardiopulonary Corp.
Company
Philips North America LLC
Model
Surveillance Monitoring System Software
Published
2017-04-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854709006074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854709006074008547090060748547090060740854709006074

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system central station monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001291111
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615041990561Capsule SurveillanceCapsule Surveillance 2024-1 PU022026-04-17
03615040000162SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-30
03615040000179SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-30
03615040000346SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-30
03615040000353SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-30
03615040000483SmartLinx Vitals PlusSL-VP-BPAP-HW2018-04-09
03615040000490SmartLinx Vitals PlusSL-VP-BPAP-HW2018-04-09
03615040000506SmartLinx Vitals PlusSL-VP-BPAP-HW2018-04-09
03615040000513SmartLinx Vitals PlusSL-VP-BPAP-HW2018-04-09
03615040000520SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15
03615040000537SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15
03615040000544SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15
03615040000551SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15
03615040000629SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15
03615040000636SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15
03615040000643SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15
03615040000087SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-27
03615040000094SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-27
03615040000261SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-27
03615040000285SmartLinx Vitals PlusSL-VP-BPAP-HW2017-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
00884838119017Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDMHX2023-08-14