DEVICE: Smartview Hotspot (08031527014647)
Device Identifier (DI) Information
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? |
---|---|---|---|---|
15271 | Electrocardiography telephone transmitter/receiver system |
An assembly of devices designed to transmit and receive electrocardiographic signals through telephone lines or the Internet. It typically includes at the transmitting site an electronic device (e.g., a modem) that modifies signals from a medical device such as an electrocardiograph (ECG) monitor or recorder for transmission through telephone lines; at the receiving end a receiver processes the incoming signal and provides an output signal for display, recording, and/or for further transmission and processing by healthcare information systems. The system is typically used to send signals from patient homes, doctor’s offices, and/or remote locations to healthcare facilities.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NVZ | Pulse generator, permanent, implantable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
828b9d9d-bf1c-4ee2-9644-88f645de1a6d
October 20, 2020
3
October 05, 2015
October 20, 2020
3
October 05, 2015
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
[?]
No Customer Contact currently defined