Wicked Smart

Primary DI
00856455007428
Brand
Wicked Smart
Company
Wicked Sheets, LLC
Model
Version 1
Published
2025-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00856455007435PackageGS11In Commercial Distribution
00856455007442PackageGS110In Commercial Distribution
00856455007459PackageGS15In Commercial Distribution
00856455007466PackageGS11In Commercial Distribution
00856455007473PackageGS11In Commercial Distribution
10856455007425PackageGS11In Commercial Distribution
20856455007422PackageGS11In Commercial Distribution
30856455007429PackageGS11In Commercial Distribution
40856455007426PackageGS11In Commercial Distribution
50856455007423PackageGS11In Commercial Distribution
60856455007420PackageGS11In Commercial Distribution
70856455007427PackageGS11In Commercial Distribution
80856455007424PackageGS11In Commercial Distribution
00856455007428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856455007435008564550074358564550074350856455007435
00856455007442008564550074428564550074420856455007442
00856455007459008564550074598564550074590856455007459
00856455007466008564550074668564550074660856455007466
00856455007473008564550074738564550074730856455007473
1085645500742510856455007425
2085645500742220856455007422
3085645500742930856455007429
4085645500742640856455007426
5085645500742350856455007423
6085645500742060856455007420
7085645500742770856455007427
8085645500742480856455007424
00856455007428008564550074288564550074280856455007428

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

Contacts#

Phone, Email table
PhoneEmail
18889779881customerservice@wickedsmartteam.com

Regulatory Flags#

DUNS number
017805579
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489082739FITRIGHTMEDLINE INDUSTRIES, INC.KPN2026-03-05
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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
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