FDA.reportPublic FDA data

Fetal Monitor Remote Display

Primary DI
B321600226100
Brand
Fetal Monitor Remote Display
Company
CLINICOMP INTERNATIONAL, INC.
Model
27 DeskTop
Published
2018-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931133000CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISPClinicomp, Inc.1995-03-29HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B321600226100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system central station monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth8Inch
Height20Inch
Weight30Pound
Width24Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003508202radine.pobuda@clinicomp.com

Regulatory Flags#

DUNS number
113412019
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B321340226010Fetal Monitor Remote Display"FMRD 4K 55"""340-226012019-11-20
B321600226110010Fetal Monitor Remote Display"27"" Wall Mount"2019-12-19
B321600226110Fetal Monitor Remote Display"27"" DeskTop"2020-04-28
B321598226010Fetal Monitor Remote DisplayNUC8i3BEK2019-12-11
B32160022611Fetal Monitor Remote Display"27"" DeskTop"2019-10-23
B32159822601Fetal Monitor Remote DisplayNUC8i3BEK2019-10-02
B32160022611001Fetal Monitor Remote Display"27"" Wall Mount"2019-09-27
B321598107300Universal Data Acquisition SystemUDAS172017-07-26
B321598221010020Fetal Monitor Remote DisplayETCX X98-1 (CM9)2016-09-22
B321598223010Fetal Monitor Remote Displayt55452016-09-22
B321598223020Fetal Monitor Remote Displayt57452016-09-22
B321598225010Fetal Monitor Remote Display4K 552016-09-22
B321598226000Fetal Monitor Remote Display4K 552017-07-11
B321600225000Fetal Monitor Remote Display27 DeskTop2016-09-22
B321600225000010Fetal Monitor Remote Display27 Wall Mount2016-09-22
B321600226000Fetal Monitor Remote Display27 DeskTop2017-06-29
B321600226000010Fetal Monitor Remote Display27 Wall Mount2017-06-29
B321600226100010Fetal Monitor Remote Display27 Wall Mount2018-06-05

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