DEVICE: Transtelephonic Receiving Module (00856298006114)

Device Identifier (DI) Information

Transtelephonic Receiving Module
Transtelephonic Receiving Module
In Commercial Distribution
100151
SCOTTCARE CORPORATION, THE
00856298006114
GS1

1
808204957 *Terms of Use
Transtelephonic receiving module for transtelephonic devices.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Medical networking interface unit An electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a 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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FDA Product Code

[?]
Product Code Product Code Name
DXH Transmitters And Receivers, Electrocardiograph, Telephone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061780 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

72370ff2-3fa2-4a97-b7aa-6a6af5b0ef7c
July 06, 2018
4
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
216-362-0550
service@scottcare.com
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