FDA.reportPublic FDA data

Kateway

Primary DI
04897041060034
Brand
Kateway
Company
Kateway Limited
Model
DM19
Device description
Yellow Dry-Me enuresis alarm (DM19)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04897041060034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897041060034048970410600344897041060034

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
669489028
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897041060010KatewayDM182016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00854950002597ShieldTheos Medical Systems, Inc.KPN2024-01-04
00854950002603ShieldTheos Medical Systems, Inc.KPN2024-01-04