Capsule Surveillance

GUDID 03615041990455

Philips North America LLC

Clinical management support software
Primary Device ID03615041990455
NIH Device Record Key8e012eee-e86d-407a-a311-8331363b0475
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapsule Surveillance
Version Model NumberCapsule Surveillance 2023-1 PU01
Company DUNS001291111
Company NamePhilips North America LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103615041990455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-16
Device Publish Date2026-01-08

On-Brand Devices [Capsule Surveillance]

03615041990554Capsule Surveillance 2024-1 HF02
03615041990547Capsule Surveillance 2024-1 PU01
03615041990516Capsule Surveillance 2024-1 HF01
03615041990509Capsule Surveillance 2023-1 PU01 HF01
03615041990486Capsule Surveillance 2024-1
03615041990479Capsule Surveillance 2023-1 PU02
03615041990455Capsule Surveillance 2023-1 PU01
03615041990431Capsule Surveillance 2023-1
03615041990394Capsule Surveillance 2022-1 PU01
03615041990363Capsule Surveillance 2022-1

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