FDA.reportPublic FDA data

Capsule Vitals Plus

Primary DI
03615040002425
Brand
Capsule Vitals Plus
Company
Philips North America LLC
Model
CAP-VP-NIBPAH-MON-HW
Device description
Vitals Plus Backpack Thermometer Exergen Capno Masimo
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
03615040002425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615040002425036150400024253615040002425

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
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
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
03615041990578Capsule SurveillancePhilips North America LLCMWI2026-07-14
04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717011556N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
00845717011563N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040112842N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040113481N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114358N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114365N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040117397N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09