STANLEY Healthcare

Basic Information

• Brand Name: STANLEY Healthcare
• Primary DI: 00840948100857
• Version / Model: TAG-P1000
• Company Name: Securitas Healthcare LLC
• Labeler DUNS: 079758354
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-06
• Public Version: 4
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 85f6bae4-edd2-4066-abb5-ac6e120f2858

Device Description

P10 Wi-Fi Pendant

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: 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
62166	Ambulatory call button	A battery-powered electronic switch intended to be carried by a patient (e.g., in the form of a patch, pendant, wristband) to initiate an alert signal for help when manually activated by the patient in need of assistance (e.g., general care, epileptic seizures, falls, low insulin levels). It typically consists of a push-button wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., central server, telephone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that 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	00840948100857	GS1