CARESCAPE SPO2

GUDID 00840682123921

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient monitoring system module, multifunction
Primary Device ID00840682123921
NIH Device Record Key57f94c09-4e57-4758-8ca4-70434a27ebe7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARESCAPE SPO2
Version Model NumberMKS101
Company DUNS784985108
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-5120
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682123921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH 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 Date2020-04-13
Device Publish Date2020-04-03

On-Brand Devices [CARESCAPE SPO2]

00840682123976MKS201
00840682123921MKS101

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