Fetal Monitor Remote Display

GUDID B321600226110010

CLINICOMP INTERNATIONAL, INC.

Centralized patient monitor Centralized patient monitor Centralized patient monitor
Primary Device IDB321600226110010
NIH Device Record Keyc0c25aa7-a845-4669-b773-10fb12207ec4
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

Phone18003508202
Emaildessi.lyakov@clinicomp.com
Phone18003508202
Emaildessi.lyakov@clinicomp.com
Phone18003508202
Emaildessi.lyakov@clinicomp.com

Device Dimensions

Depth5 Inch
Height24 Inch
Width14.5 Inch
Weight16 Pound
Depth5 Inch
Height24 Inch
Width14.5 Inch
Weight16 Pound
Depth5 Inch
Height24 Inch
Width14.5 Inch
Weight16 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB321600226110010 [Primary]
HIBCCB321600226110010 [Primary]
HIBCCB321600226110010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, Monitoring, Perinatal
HGMSystem, Monitoring, Perinatal
HGMSystem, Monitoring, Perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2019-12-19

On-Brand Devices [Fetal Monitor Remote Display]

B32160022610001027 Wall Mount
B32160022610027 DeskTop
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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