DEVICE: BCL-MS (00199284085701)

Device Identifier (DI) Information

BCL-MS
MS 2.1
In Commercial Distribution
BCL-MS
BeCare Link, LLC
00199284085701
GS1

1
080993252 *Terms of Use
BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
58884 Self-care monitoring/reporting software
An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OUG Medical Device Data System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

c2e4d858-0ba0-4e24-b77b-1c4d778bc7d4
July 10, 2025
1
July 02, 2025
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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
No
No
No
No CLOSE

Customer Contact

[?]
7323710030
support@becare.net
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