DEVICE: Fetal Monitor Remote Display (B321598223010)
Device Identifier (DI) Information
Fetal Monitor Remote Display
t5545
In Commercial Distribution
CLINICOMP INTERNATIONAL, INC.
t5545
In Commercial Distribution
CLINICOMP INTERNATIONAL, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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38470 | Centralized patient monitor |
A 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)].
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HGM | System, Monitoring, Perinatal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K931133 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: less than 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 3.5 Pound |
Depth: 9 Inch |
Height: 8 Inch |
Width: 2 Inch |
Device Record Status
5377476d-f2bd-4f9e-963f-d89816ac11ad
May 19, 2020
4
September 22, 2016
May 19, 2020
4
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8003508202
radine.pobuda@clinicomp.com
radine.pobuda@clinicomp.com