CARESCAPE Central Station

GUDID 00840682109604

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient monitoring system central station monitor
Primary Device ID00840682109604
NIH Device Record Key3561396b-922b-4899-8ad7-2ca1be1d732a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARESCAPE Central Station
Version Model NumberV2 Standard MAS 700
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1075 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1075 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1075 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1075 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682109604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-11

On-Brand Devices [CARESCAPE Central Station]

00840682109666V2 Integrated MAI 700
00840682109604V2 Standard MAS 700

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