FDA.reportPublic FDA data

GoSafe / HomeSafe Personal Help Pendant

Primary DI
00884838100008
Brand
GoSafe / HomeSafe Personal Help Pendant
Company
Lifeline Systems Company
Model
300004873261
Catalog number
7000PHB
Device description
7000PHB Personal Help Button
Published
2021-04-02
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
00884838100008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838100008008848381000088848381000080884838100008

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
00884838100077HomeSafe Standard Personal Help Wriststrap300005057771324PHW2021-04-29
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
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00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010371Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010395Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
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00812324010432Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
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00812324010470Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
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00812324010494Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
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