FDA.reportPublic FDA data

Capsule Vitals Plus

Primary DI
03615040001800
Brand
Capsule Vitals Plus
Company
Philips North America LLC
Model
CAP-VP-NIBPAH-MON-HW
Device description
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
Published
2022-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
DQAOximeter
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210204000Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas2021-10-19MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615040001800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615040001800036150400018003615040001800

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, interfacingA small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001291111
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
06924054300623BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-06-04
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00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
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08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
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