FDA.reportPublic FDA data

Capsule Surveillance

Primary DI
03615041990561
Brand
Capsule Surveillance
Company
Philips North America LLC
Model
Capsule Surveillance 2024-1 PU02
Published
2026-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213335000Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.2022-01-14MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615041990561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615041990561036150419905613615041990561

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Regulatory Flags#

DUNS number
001291111
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03615040000513SmartLinx Vitals PlusSL-VP-BPAP-HW2018-04-09
03615040000520SmartLinx Vitals PlusSL-VP-BPAP-HW2019-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08684906452600Arc SystemM2AN DIGITAL HEALTH INC.MWI2026-06-29
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201017Gas Sample Line SetMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.MWI2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.MWI2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27