FDA.reportPublic FDA data

Chummie

Primary DI
00854950002702
Brand
Chummie
Company
Theos Medical Systems, Inc.
Model
TCE25O
Device description
A 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.
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00854950002191PreviousGS10
00854950002702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854950002191008549500021918549500021910854950002191
00854950002702008549500027028549500027020854950002702

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
808427392
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854950002689ChummieTCE25B2026-01-01
00854950002696ChummieTCE25P2026-01-01
00854950002719ChummieTCE25G2026-01-01
00854950002023ChummieTC300B2024-01-04
00854950002030ChummieTC300P2024-01-04
00854950002047ChummieTCI3002024-01-04
00854950002078ChummieTC310B2024-01-04
00854950002085ChummieTC310P2024-01-04
00854950002153ChummieTC300G2024-01-04
00854950002177ChummieTCE25B2024-01-04
00854950002184ChummieTCE25P2024-01-04
00854950002191ChummieTCE25O2024-01-04
00854950002207ChummieTCE25G2024-01-04
00854950002269GuardianTGV65W2024-01-04
00854950002283ShieldTSM45G2024-01-04
00854950002290ShieldTSM45S2024-01-04
00854950002320ChummieTC310G2024-01-04
00854950002559NewUTNU4B2024-01-04
00854950002566SmartTSV55W2024-01-04
00854950002573ZestTZT4G2024-01-04

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
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