FDA.reportPublic FDA data

Pjama

Primary DI
07350078445078
Brand
Pjama
Company
Pjama AB
Model
Treatment Boxers Underwear darkblue- Size 194 XL
Catalog number
4137
Device description
Treatment Boxer/ Briefs Underwear featuring integrated sensor threads. Effortlessly connect the Pjama Bedwetting Alarm or Pjama Sensor with Smartphone to this underwear for seamless treatment. Connecting the Pjama Sensor is a breeze—simply attach it to the two small buttons near the waist of the treatment underwear. This establishes wireless communication with the bedwetting alarm unit or your smartphone, facilitating effective monitoring and treatment. This treatment underwear is laundry-friendly, suitable for washing in the machine at 60°C and tumble drying.
Published
2023-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
07350078445078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350078445078073500784450787350078445078

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
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
true
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
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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