DEVICE: Transtelephonic Receiving Module (00856298006114)
Device Identifier (DI) Information
Transtelephonic Receiving Module
Transtelephonic Receiving Module
In Commercial Distribution
100151
SCOTTCARE CORPORATION, THE
Transtelephonic Receiving Module
In Commercial Distribution
100151
SCOTTCARE CORPORATION, THE
Transtelephonic receiving module for transtelephonic devices.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061780 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
72370ff2-3fa2-4a97-b7aa-6a6af5b0ef7c
November 10, 2021
5
September 19, 2016
November 10, 2021
5
September 19, 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
[?]
216-362-0550
service@scottcare.com
service@scottcare.com