Fetal Monitor Remote Display

GUDID B321600226100010

CLINICOMP INTERNATIONAL, INC.

Patient monitoring system central station monitor Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor
Primary Device IDB321600226100010
NIH Device Record Keyde02bd04-8d2e-43b0-93dd-867332667864
Commercial Distribution StatusIn Commercial Distribution
Brand NameFetal Monitor Remote Display
Version Model Number27 Wall Mount
Company DUNS113412019
Company NameCLINICOMP INTERNATIONAL, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8003508202
Emailradine.pobuda@clinicomp.com
Phone8003508202
Emailradine.pobuda@clinicomp.com
Phone8003508202
Emailradine.pobuda@clinicomp.com
Phone8003508202
Emailradine.pobuda@clinicomp.com
Phone8003508202
Emailradine.pobuda@clinicomp.com

Device Dimensions

Depth3.5 Inch
Width24 Inch
Height17 Inch
Weight24 Pound
Depth3.5 Inch
Width24 Inch
Height17 Inch
Weight24 Pound
Depth3.5 Inch
Width24 Inch
Height17 Inch
Weight24 Pound
Depth3.5 Inch
Width24 Inch
Height17 Inch
Weight24 Pound
Depth3.5 Inch
Width24 Inch
Height17 Inch
Weight24 Pound

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB321600226100010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, Monitoring, Perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-06-05

On-Brand Devices [Fetal Monitor Remote Display]

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B32160022600001027 Wall Mount
B32160022600027 DeskTop
B32160022500001027 Wall Mount
B32160022500027 DeskTop
B3215982260004K 55
B3215982250104K 55
B321598223020t5745
B321598223010t5545
B321598221010020ETCX X98-1 (CM9)
B3216002261100127" Wall Mount
B32159822601NUC8i3BEK
B3216002261127" DeskTop
B321598226010NUC8i3BEK
B32160022611027" DeskTop
B32160022611001027" Wall Mount
B321340226010FMRD 4K 55"

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