FDA.reportPublic FDA data

Bernoulli

Primary DI
00854709006029
Brand
Bernoulli
Company
Philips North America LLC
Model
Bernoulli One Software
Published
2017-12-05
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
MSXSystem,Network And Communication,Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091461000BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUECardiopulmonary Corp.2009-08-14MOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854709006029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854709006029008547090060298547090060290854709006029

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
03615041990578Capsule SurveillanceCapsule Surveillance 2024-1 PU032026-07-14
03615041990561Capsule SurveillanceCapsule Surveillance 2024-1 PU022026-04-17
03615041990363Capsule SurveillanceCapsule Surveillance 2022-12026-01-08
03615041990394Capsule SurveillanceCapsule Surveillance 2022-1 PU012026-01-08
03615041990431Capsule SurveillanceCapsule Surveillance 2023-12026-01-08
03615041990455Capsule SurveillanceCapsule Surveillance 2023-1 PU012026-01-08
03615041990479Capsule SurveillanceCapsule Surveillance 2023-1 PU022026-01-08
03615041990486Capsule SurveillanceCapsule Surveillance 2024-12026-01-08
03615041990509Capsule SurveillanceCapsule Surveillance 2023-1 PU01 HF012026-01-08
03615041990516Capsule SurveillanceCapsule Surveillance 2024-1 HF012026-01-08
03615041990547Capsule SurveillanceCapsule Surveillance 2024-1 PU012026-01-08
03615041990554Capsule SurveillanceCapsule Surveillance 2024-1 HF022026-01-08
03615041990332Capsule SurveillanceCapsule Surveillance System2022-05-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-07-13
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.MSX2026-06-02
08720256776659Strap Silicon BlueCorsano Health B.V.MSX2026-06-02
08720256776987Charge Station 10 Sensors ACorsano Health B.V.MSX2026-06-02
00860006582012TigerConnect Alarm ManagementCritical AlertMSX2026-05-29
00884838107816Measurement Rack 6000Philips Medizin Systeme Böblingen GmbHMSX2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MSX2026-03-18
B153301030AirStrip ONE Client WebAirstrip Technologies, Inc.MSX2026-03-18
B153500010AirStrip Alarm ManagementAirstrip Technologies, Inc.MSX2026-03-18
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00843997019019Patient SafetyNet LiteMASIMO CORPORATIONMSX2026-02-23
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyMSX2025-12-10
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCMSX2025-06-30
00853858006584EmpaticaEMPATICA SRLMSX2025-06-26
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
G2871002HUMAMedoPad Inc.MSX2025-04-28
00850064210262Sibel Spacelabs Trek TabletSibel Health Inc.MSX2025-04-02
00850064210163Central Hub CMSSibel Health Inc.MSX2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.MSX2025-03-27