FDA.reportPublic FDA data

Malem

Primary DI
05060049630298
Brand
Malem
Company
MALEM MEDICAL LIMITED
Model
MO4SM
Device description
Malem Ultimate Selectable (MO4S) enuresis alarm (magenta)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KPNAlarm, Conditioned Response Enuresis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPNAlarm, Conditioned Response EnuresisGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060049630298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060049630298050600496302985060049630298

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence sensor/alarmA electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
291490076
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060049630038MalemMO3S12016-08-31
05060049630045MalemMO48T2016-08-31
05060049630052MalemMO5M2016-08-31
05060049630069MalemMO62016-08-31
05060049630076MalemMO72016-08-31
05060049630120MalemMO4SB2016-08-31
05060049630151MalemMO122016-08-31
05060049630168MalemMO152016-08-31
05060049630182MalemMO172016-08-31
05060049630205MalemMO38T2016-08-31
05060049630212MalemMO3S22016-08-31
05060049630229MalemMO3S32016-08-31
05060049630236MalemMO38TC2016-08-31
05060049630243MalemMO3V2016-08-31
05060049630250MalemMO4S12016-08-31
05060049630267MalemMO4S22016-08-31
05060049630274MalemMO4S32016-08-31
05060049630281MalemMO5B2016-08-31
05060049630304MalemMO4SC2016-08-31
05060049630366MalemMO242016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489082739FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
00193489036414FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
10193489036411FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
20193489082736FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
00619013000015DRI Sleeper excelANZACARE LIMITEDKPN2026-02-16
00619013000039DRI Sleeper eclipseANZACARE LIMITEDKPN2026-02-16
00619013000183DRI Sleeper eclipse plusANZACARE LIMITEDKPN2026-02-16
00854950002689ChummieTheos Medical Systems, Inc.KPN2026-01-01
00854950002696ChummieTheos Medical Systems, Inc.KPN2026-01-01
00854950002702ChummieTheos Medical Systems, Inc.KPN2026-01-01
00854950002719ChummieTheos Medical Systems, Inc.KPN2026-01-01
00856455007428Wicked SmartWicked Sheets, LLCKPN2025-11-19
00854950002023ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002030ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002047ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002078ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002085ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002153ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002177ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002184ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002191ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002207ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002269GuardianTheos Medical Systems, Inc.KPN2024-01-04
00854950002283ShieldTheos Medical Systems, Inc.KPN2024-01-04
00854950002290ShieldTheos Medical Systems, Inc.KPN2024-01-04
00854950002320ChummieTheos Medical Systems, Inc.KPN2024-01-04
00854950002559NewUTheos Medical Systems, Inc.KPN2024-01-04
00854950002566SmartTheos Medical Systems, Inc.KPN2024-01-04
00854950002573ZestTheos Medical Systems, Inc.KPN2024-01-04
00854950002580SmartTheos Medical Systems, Inc.KPN2024-01-04