FDA.reportPublic FDA data

HomeSafe Standard Personal Help Wriststrap

Primary DI
00884838100077
Brand
HomeSafe Standard Personal Help Wriststrap
Company
Lifeline Systems Company
Model
300005057771
Catalog number
324PHW
Device description
324PHW Personal Help Buton / Wriststrap
Published
2021-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILQSystem, communication, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838100077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838100077008848381000778848381000770884838100077

GMDN Terms#

Term, Definition table
TermDefinition
Home alert systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080030042
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959015395ComfortGel0010700562015-11-05
00884838100046Senior Living Personal Help Device Pendant300005057751319PHB2021-04-29
00884838100053Senior Living Personal Help Device Wriststrap300005057731319PHW2021-04-29
00884838100060HomeSafe Standard Personal Help Pendant300005057791324PHB2021-04-29
00884838100008GoSafe / HomeSafe Personal Help Pendant3000048732617000PHB2021-04-02
00884838100015Senior Living Alert Device Personal Help Pendant with Indicator3000048733217000PHB-SL2021-04-02
00884838100022GoSafe / HomeSafe Personal Help Wriststrap3000048733317000PHW2021-04-02
00884838100039Senior Living Alert Device Personal Help Wriststrap with Indicator3000048733517000PHW-SL2021-04-02
00884838099968GoSafe / HomeSafe AutoAlert Pendant3000004911317000AHB2021-03-19
00884838099975Senior Living Alert Device AutoAlert with Indicator3000004911517000AHB-SL2021-03-19
00884838099982HomeSafe AutoAlert Pendant300000491111FD1002021-03-19
00884838099999Senior Living Alert Device AutoAlert300000491121FD100-SL2021-03-19
00884838093638Philips GoSafe 23000027063117250MHB2020-07-10
00884838091573Philips GoSafe 23000025669817150MHB2019-06-01
00884838091580Philips GoSafe3000025669717100MHB2019-06-01
00884838097551Philips BlueBand300004069001BBM01102020-01-01
00884838096776HomeSafe (Wireless) Home Communicator3000034728217200C2019-11-01
00884838094048HomeSafe Standard Home Communicator3000029856516903AT2019-07-02
00884838088597HomeSafe Standard Personal Help Pendant300001287651324PHB2019-05-16
00884838088603HomeSafe Standard Personal Help Wriststrap300001287661324PHW2019-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196468RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-05-27
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
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00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
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00812324010500Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010517Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010524Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010531Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010548Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010555Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010586Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13