DEVICE: TeleSentry Battery (00856298006046)

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Device Identifier (DI) Information

TeleSentry Battery
TS01
101109B
SCOTTCARE CORPORATION, THE
00856298006046
GS1
1
3.7V Rechargeable Lithium Polymer battery for use in TeleSentry 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
Multichannel electrocardiograph, interpretive, professional An instrument designed to be used by a healthcare professional in a clinical setting to measure electrical potentials on the body surface to produce a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple-electrode sets (leads) simultaneously, to facilitate interpretation of the record by enabling comparison of multiple-lead recordings of the same heartbeat. It performs a computerized analysis of the signals using an internal algorithm and typically provides a print-out ECG with a suggested interpretation and waveform component measurements.
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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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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 Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 70 Degrees Celsius
Handling Environment Humidity: between 25 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 45 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 11, 2017

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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
800-243-9412
service@scottcare.com
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