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
00856298006077
GS1

1
808204957 *Terms of Use
Cardiac Rehab 3 Lead patient cable used to connect to Angel and Innovo transmitters.
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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
Electrocardiograph, professional, single-channel A device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel) but may otherwise include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included. It is intended to be used by a healthcare professional in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050778 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
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a5680974-1a1a-4828-9d39-6e1db09ec7b1
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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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