CareSentinell

Basic Information

• Brand Name: CareSentinell
• Primary DI: B1751CB11
• Version / Model: CB11
• Catalog Number: CB11
• Company Name: LOON MEDICAL, INC.
• Labeler DUNS: 079266770
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-06
• Public Version: 3
• Public Version Date: 2021-05-06
• Public Version Status: Update
• Public Device Record Key: 08a09e0f-6f64-47f8-a9c7-096292eb60dc
• Distribution End Date: 2021-05-06

Device Description

CareSentinel call button

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQA	System, Environmental Control, Powered	Physical Medicine	890.3725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37991	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1751CB11	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]