DEVICE: CareSentinell (B1751CB11)

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Device Identifier (DI) Information

CareSentinell
CB11
CB11
LOON MEDICAL, INC.
B1751CB11
HIBCC
1
CareSentinel call button
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bed remote control A hand-operated electronic device that has a functional connection to an electrically-powered medical bed to control its functions, typically the articulations and/or the raising/lowering of the bed. It may be connected to the bed via an electrical cable or operate cordless (wireless). It is typically operated by the occupant but may be utilized by the nursing/attending staff. Some types may integrate other functions for patient use (e.g., communication with the staff, radio/television operation).
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FDA Product Code

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Product Code Product Code Name
IQA System, Environmental Control, Powered
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
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 Status

In Commercial Distribution
May 06, 2016
May 06, 2021
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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
8552820004
info@loonmedical.com
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