Philips GoSafe

Basic Information

• Brand Name: Philips GoSafe
• Primary DI: 00884838091580
• Version / Model: 300002566971
• Catalog Number: 7100MHB
• Company Name: Lifeline Systems Company
• Labeler DUNS: 080030042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-01
• Public Version: 2
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: dc08a457-7504-4436-be19-0d0d76e2104f

Device Description

7100MHB (GoSafe)

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: Yes
• 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
ILQ	System, communication, powered	Physical Medicine	890.3710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30087	Vulnerable patient home alert system	An assembly of electronic devices designed to provide an alarm signal to summon help when activated in response to a patient’s need for urgent assistance or care (e.g., epileptic seizures, falls, low insulin levels). It typically consists of user- or sensor-activated wireless signal transmitters (e.g., patient-worn pendant, wall push-button, fall sensor) and alert communication devices (e.g., network interface, phone, pager). Also known as a personal emergency response system (PERS), it notifies caregivers, neighbours, or emergency medical services (EMS), and is intended for use in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838091580	GS1