FDA.reportPublic FDA data

Pjama

Primary DI
07350078440462
Brand
Pjama
Company
Pjama AB
Model
Pjama Bedwetting Pants Blue Age 3-4 - 98/104
Catalog number
2001
Device description
Pjama Bedwetting Pants—an innovative solution designed for children experiencing bedwetting. Pjama pants are crafted to be waterproof, breathable, and secure, ensuring a comfortable night's sleep. Experience the softness and comfort of Pjama Bedwetting Pants, providing peace of mind for both parents and children. In the event of a nighttime accident, the pants effectively contain urine, keeping the bed dry. Simply toss them in the washing machine (maximum 60 degrees C), centrifuge, hang to dry (or tumble dry), and they're ready for reuse.
Published
2023-12-01
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
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350078440462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350078440462073500784404627350078440462

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, reusableAn underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a reusable man?s brief or woman?s panty with external softness and shape resembling regular underwear, and a disposable pant liner and/or a tube that deliver the urine to a bag placed on or around one leg. The device is typically used for patients with heavy urinary incontinence in healthcare facilities or at home.

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
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
07350078441025PjamaPjama Treatment Pants Grey Age 6-8 - 122/128 90032023-11-15

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