DEVICE: GD (00862186000379)
Device Identifier (DI) Information
GD
CAREpoint Workstation
In Commercial Distribution
040-183-4000
General Devices
CAREpoint Workstation
In Commercial Distribution
040-183-4000
General Devices
The CAREpoint Workstation communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
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? |
---|---|---|---|---|
32547 | Medical networking interface unit |
An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013533 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
19d79e94-1462-4839-9554-dbf8ff33a2ae
November 10, 2021
5
September 23, 2016
November 10, 2021
5
September 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
No Customer Contact currently defined