Capsule Vitals Plus

GUDID 03615040002388

Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen

CAPSULE TECHNOLOGIE

Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing

Primary Device ID	03615040002388
NIH Device Record Key	400ba96a-996f-4c7a-b5dd-fd657f405856
Commercial Distribution Status	In Commercial Distribution
Brand Name	Capsule Vitals Plus
Version Model Number	CAP-VP-NIBPAH-MON-HW
Company DUNS	536805245
Company Name	CAPSULE TECHNOLOGIE
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615040002388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210204

FDA Product Code

MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-10
Device Publish Date	2022-03-02

On-Brand Devices [Capsule Vitals Plus]

03615040002449	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen Capno Masimo
03615040002432	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo
03615040002425	Vitals Plus Backpack Thermometer Exergen Capno Masimo
03615040002418	Vitals Plus Backpack Oximeter Nellcor Capno Masimo
03615040002401	Vitals Plus Backpack Oximeter Masimo Capno Masimo
03615040002395	Vitals Plus Backpack Capno Masimo
03615040002388	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
03615040002371	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
03615040002364	Vitals Plus Backpack Thermometer Exergen
03615040002357	Vitals Plus Backpack Oximeter Nellcor
03615040002340	Vitals Plus Backpack Oximeter Masimo
03615040002333	Vitals Plus Backpack
03615040002326	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen Capno Masimo
03615040002319	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo
03615040002302	Vitals Plus Backpack Thermometer Exergen Capno Masimo
03615040002296	Vitals Plus Backpack Oximeter Nellcor Capno Masimo
03615040002289	Vitals Plus Backpack Oximeter Masimo Capno Masimo
03615040002272	Vitals Plus Backpack Capno Masimo
03615040002265	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
03615040002258	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
03615040002241	Vitals Plus Backpack Thermometer Exergen
03615040002234	Vitals Plus Backpack Oximeter Nellcor
03615040002227	Vitals Plus Backpack Oximeter Masimo
03615040002210	Vitals Plus Backpack
03615040001992	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen Capno Masimo
03615040001985	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo
03615040001978	Vitals Plus Backpack Thermometer Exergen Capno Masimo
03615040001961	Vitals Plus Backpack Oximeter Nellcor Capno Masimo
03615040001954	Vitals Plus Backpack Oximeter Masimo Capno Masimo
03615040001947	Vitals Plus Backpack Capno Masimo
03615040001930	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
03615040001923	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
03615040001916	Vitals Plus Backpack Thermometer Exergen
03615040001909	Vitals Plus Backpack Oximeter Nellcor
03615040001893	Vitals Plus Backpack Oximeter Masimo
03615040001886	Vitals Plus Backpack
03615040001879	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen Capno Masimo
03615040001862	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo
03615040001855	Vitals Plus Backpack Thermometer Exergen Capno Masimo
03615040001848	Vitals Plus Backpack Oximeter Nellcor Capno Masimo
03615040001831	Vitals Plus Backpack Oximeter Masimo Capno Masimo
03615040001824	Vitals Plus Backpack Capno Masimo
03615040001817	Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
03615040001800	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
03615040001794	Vitals Plus Backpack Thermometer Exergen
03615040001787	Vitals Plus Backpack Oximeter Nellcor
03615040001770	Vitals Plus Backpack Oximeter Masimo
03615040001763	Vitals Plus Backpack
03615040001749	Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo
03615040001732	Vitals Plus Backpack Thermometer Exergen Capno Masimo