Pjama

Basic Information

• Brand Name: Pjama
• Primary DI: 07350078441308
• Version / Model: Pjama Bedwetting Alarm
• Catalog Number: 9031
• Company Name: Pjama AB
• Labeler DUNS: 350245517
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-15
• Public Version: 1
• Public Version Date: 2023-11-23
• Public Version Status: New
• Public Device Record Key: 23caa080-ce20-4262-8973-188798f98cf1
• Distribution End Date: 2026-12-31

Device Description

Pjama Bedwetting Alarm—a comprehensive solution for addressing bedwetting when connected to Pjama Treatment Pants/Shorts/Briefs/Boxers.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPN	Alarm, Conditioned Response Enuresis	Gastroenterology, Urology	876.2040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11588	Incontinence sensor/alarm	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350078441308	GS1