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.
|
Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NVZ | Pulse generator, permanent, implantable |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| 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 |
|---|---|---|---|---|---|
| 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