Fetal Monitor Remote Display 340-22601

GUDID B321340226010

CLINICOMP INTERNATIONAL, INC.

Centralized patient monitor Centralized patient monitor Centralized patient monitor
Primary Device IDB321340226010
NIH Device Record Key0a101920-7296-45cd-a412-25a3b2f59895
Commercial Distribution StatusIn Commercial Distribution
Brand NameFetal Monitor Remote Display
Version Model NumberFMRD 4K 55"
Catalog Number340-22601
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
EmailDessi.Lyakov@clinicomp.com
Phone8003508202
EmailDessi.Lyakov@clinicomp.com
Phone8003508202
EmailDessi.Lyakov@clinicomp.com

Device Dimensions

Height28 Inch
Length49 Inch
Weight42 Pound
Height28 Inch
Length49 Inch
Weight42 Pound
Height28 Inch
Length49 Inch
Weight42 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
HIBCCB321340226010 [Primary]
HIBCCB321340226010 [Primary]
HIBCCB321340226010 [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 Date2019-11-20

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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