DEVICE: LATITUDE® Communicator (00802526585609)

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Device Record History
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Device Identifier (DI) Information
LATITUDE® Communicator
6290
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
00802526585609
GS1

1
106295384 *Terms of Use
LATITUDE ™ Communicator
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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?
32547 Medical networking interface unit
An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OSR Pacemaker/icd/crt non-implanted components
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P910077 151
P910077 154
P910077 156
P910077 157
P910077 160
P910077 162
P910077 168
P910077 176
P910077 180
P910077 185
P910077 188
P910077 191
P910077 194
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
396e146e-6b0d-4292-a4bc-2f1856afe1d9
August 02, 2024
12
July 22, 2016
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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
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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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