AccessGUDID - DEVICE: HomeSafe Standard Slimline Personal Help Wriststrap (00884838071827)

GUDID

Device Identifier (DI) Information

Brand Name: HomeSafe Standard Slimline Personal Help Wriststrap
Version or Model: 1840478
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SE324G
Company Name: Lifeline Systems Company

Primary DI Number: 00884838071827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080030042 *Terms of Use

Device Description: SE324G Personal Help Button/Wriststrap

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILQ	System, communication, powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 884eaae5-4030-40db-9537-4b0121394723
Public Version Date: October 19, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2016