Capsule Surveillance

GUDID 03615041990332

CAPSULE TECHNOLOGIE

Clinical management support software
Primary Device ID03615041990332
NIH Device Record Keyd0c7fcbc-9762-4465-bb1e-c72848b3016c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapsule Surveillance
Version Model NumberCapsule Surveillance System
Company DUNS536805245
Company NameCAPSULE TECHNOLOGIE
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
GS103615041990332 [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 Date2022-05-31
Device Publish Date2022-05-23

Devices Manufactured by CAPSULE TECHNOLOGIE

03615041990332 - Capsule Surveillance2022-05-31
03615041990332 - Capsule Surveillance2022-05-31
03615040001640 - Capsule Vitals Plus2022-03-10 Vitals Plus Backpack
03615040001657 - Capsule Vitals Plus2022-03-10 Vitals Plus Backpack Oximeter Masimo
03615040001664 - Capsule Vitals Plus2022-03-10 Vitals Plus Backpack Oximeter Nellcor
03615040001671 - Capsule Vitals Plus2022-03-10 Vitals Plus Backpack Thermometer Exergen
03615040001688 - Capsule Vitals Plus2022-03-10 Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
03615040001695 - Capsule Vitals Plus2022-03-10 Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
03615040001701 - Capsule Vitals Plus2022-03-10 Vitals Plus Backpack Capno Masimo

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