Smart Caregiver

Basic Information

• Brand Name: Smart Caregiver
• Primary DI: 00812293015124
• Version / Model: TM-FM
• Company Name: Smart Caregiver Corporation
• Labeler DUNS: 012082397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-10
• Public Version: 1
• Public Version Date: 2022-06-21
• Public Version Status: New
• Public Device Record Key: a6132262-4496-4e86-a8b4-ad8b2cf50c33

Device Description

Transmitter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
KMI	Monitor, Bed Patient	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36693	Ambulatory fall sensor	A battery-powered electronic device intended to be worn on a patient’s body (e.g., in the form of a patch, pendant, wristband) to provide an alert signal for help when automatically activated in response to an event requiring need for assistance or care, typically in cases of falls or epileptic seizures. It consists of a sensor with a wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that urgent assistance is needed. It is intended to be used in the home and healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812293015124	GS1