DEVICE: Telemetry 3 Lead Patient Cable (00856298006077)
Device Identifier (DI) Information
Telemetry 3 Lead Patient Cable
Telemetry 3 Lead Patient Cable
In Commercial Distribution
100233
SCOTTCARE CORPORATION, THE
Telemetry 3 Lead Patient Cable
In Commercial Distribution
100233
SCOTTCARE CORPORATION, THE
Cardiac Rehab 3 Lead patient cable used to connect to Angel and Innovo transmitters.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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11413 | Electrocardiograph, professional, single-channel |
A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K050778 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a5680974-1a1a-4828-9d39-6e1db09ec7b1
March 10, 2021
5
September 19, 2016
March 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 |
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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
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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