FDA.reportPublic FDA data

REPLACEMENT MAGNETS FOR WORRYFREE PULL-CORD ALARM 10/PK

Primary DI
00733657217483
Brand
REPLACEMENT MAGNETS FOR WORRYFREE PULL-CORD ALARM 10/PK
Company
ALIMED, INC.
Model
710100
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMIMONITOR, BED PATIENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733657217483PrimaryGS10
00733657299021Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657217483007336572174837336572174830733657217483
00733657299021007336572990217336572990210733657299021

GMDN Terms#

Term, Definition table
TermDefinition
Vulnerable patient 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

Contacts#

Phone, Email table
PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags#

DUNS number
056007248
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733657301038ATEC KIT 4 STRAPS96114529700181532024-08-02
00733657288667ATEC STRAP 2 X 84IN 2 CLOSURE PELVIC LONG96119629700182042024-08-02
00733657288674ATEC STRAP 2 X 72IN 2 CLOSURE PELVIC SHORT96119729700182052024-08-02
00733657288681ATEC STRAP 2 X 42IN 2 CLOSURE THORACIC96119829700182062024-08-02
00733657230253CUSH DROP AWAY POMMEL 16X168892429700113712022-12-15
00733657230260DROP AWAY POMMEL CUSHION 18X168892529700113722022-12-15
00733657240054CATH LAB IMMOBILIZER93189829700134112022-12-15
00733657245035STRAP UNIVERSAL UNIBODY, 5WX65L9-93129700188652022-12-15
00733657283594STRAP UNIVERSAL 3IN X 72IN 10/PK75361029700099892022-12-15
00733657283600STRAP UNIVERSAL 3IN X 72IN 25/PK62575362529700099912022-12-15
00733657283624STRAP UNIVERSAL 4IN x 72IN 10/PK75391029700099962022-12-15
00733657283631STRAP UNIVERSAL 4IN x 72IN 25/PK75392529700099982022-12-15
00733657283648STRAP UNIVERSAL 4IN x 72IN 50/PK75395029700099992022-12-15
00733657283662STRAP UNIVERSAL 4IN x 72IN 100/PK753910029700099972022-12-15
00733657290684ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS31716032022-12-01
00656204000201HARNESS PAVLIK TYPE51968/NA/LG2022-12-01
00656204000218HARNESS PAVLIK TYPE51968/NA/MD2022-12-01
00656204000225HARNESS PAVLIK TYPE51968/NA/SM2022-12-01
00656204000232HARNESS PAVLIK TYPE51968/NA/XL2022-12-01
00656204004940AFO CHILD LEFT66132/NA/LL2022-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199874390529Nightwatch Bedroom ModuleLutso Inc.KMI2026-03-06
05000223503956LEAFSMITH & NEPHEW MEDICAL LIMITEDKMI2026-03-03
05000223503994LEAFSMITH & NEPHEW MEDICAL LIMITEDKMI2026-03-01
10618125192325POSEYTIDI PRODUCTS, LLCKMI2025-12-04
00840828195416UNDER BED LIGHT CONTROLLER ASSEMBLYCURBELL MEDICAL PRODUCTS, INC.KMI2025-11-25
00840948103339Securitas HealthcareSecuritas Healthcare LLCKMI2025-09-26
00840948103346Securitas HealthcareSecuritas Healthcare LLCKMI2025-09-26
00860007550263Cubby BedsSensory Medical, Inc.KMI2025-01-31
20080196373236MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
40080196750116MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
20193489001928MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-28
00840828193405SAFE MOBILITY LIGHT KIT,XMIT,PAD,PWR 8'CURBELL MEDICAL PRODUCTS, INC.KMI2024-11-08
10193489001648MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-08
00840948103285Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103292Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103308Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103315Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
00840948103322Securitas HealthcareSecuritas Healthcare LLCKMI2024-10-29
20193489036630MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-10-25
00190676007653PoseyPOSEY PRODUCTS, LLCKMI2024-10-23
30023601033049CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.KMI2024-09-30
30023601033056CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.KMI2024-09-30
00840828192712UNDER BED LIGHT CONTROLLER ASSEMBLYCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-22
10197344103744MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-07-22
00840828192132UNI CHAIR SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
10840828192146UNI BED SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
04719873790050BriteMED Technology Inc.BRITEMED TECHNOLOGY INC.KMI2024-06-04
00850064651034Bed4Foresite Healthcare, LLCKMI2024-05-24
00850064651072Bed4Foresite Healthcare, LLCKMI2024-05-24