FDA.reportPublic FDA data

Pjama

Primary DI
07350078441315
Brand
Pjama
Company
Pjama AB
Model
Pjama Speaker
Catalog number
9032
Published
2023-11-15
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
07350078441315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350078441315073500784413157350078441315

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
350245517
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350078440462PjamaPjama Bedwetting Pants Blue Age 3-4 - 98/10420012023-12-01
07350078440288PjamaPjama Bedwetting Shorts Blue Age 3-4 - 98/10420202023-11-15
07350078440301PjamaPjama Bedwetting Shorts Blue Age 5-6 - 110/116 20222023-11-15
07350078440325PjamaPjama Bedwetting Shorts Blue Age 6-8 - 122/128 20242023-11-15
07350078440349PjamaPjama Bedwetting Shorts Blue Age 8-10 - 134/14020262023-11-15
07350078440363PjamaPjama Bedwetting Shorts Blue Age 10-12 - 146/15220282023-11-15
07350078440394PjamaPjama Bedwetting Shorts Blue- Small - 158/164 20312023-11-15
07350078440417PjamaPjama Bedwetting Shorts Blue - Medium -170/176 20332023-11-15
07350078440431PjamaPjama Bedwetting Shorts Blue Large -182/188 20352023-11-15
07350078440455PjamaPjama Bedwetting Shorts Blue - Xlarge -194 20372023-11-15
07350078440486PjamaPjama Bedwetting Pants Blue Age 5-6 - 110/11620042023-11-15
07350078440509PjamaPjama Bedwetting Pants Blue Age 6-8 - 122/128 20072023-11-15
07350078440523PjamaPjama Bedwetting Pants Blue Age 8 - 10 - 134/140 20102023-11-15
07350078440547PjamaPjama Bedwetting Pants Blue Age 10-12 - 146/152 20132023-11-15
07350078440578PjamaPjama Bedwetting Pants Blue 158/164 SMALL20182023-11-15
07350078440592PjamaPjama Bedwetting Pants Blue 170/176 MEDIUM30252023-11-15
07350078440615PjamaPjama Bedwetting Pants Blue 182/188 LARGE30272023-11-15
07350078440639PjamaPjama Bedwetting Pants Blue 194 X-XXLARGE30232023-11-15
07350078441001PjamaPjama Treatment Pants Grey Age 3-4 - 98/104 90012023-11-15
07350078441018PjamaPjama Treatment Pants Grey Age 5-6 - 110/11690022023-11-15

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Primary DI, Brand, Company table
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