FDA UDI
In Commercial Distribution
🇺🇸 United States
Pjama
DI: 07350078441902
·
Model: Treatment Boxers Underwear darkblue- Size 170/176
·
Pjama AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pjama
- Primary DI
- 07350078441902
- Version / Model
- Treatment Boxers Underwear darkblue- Size 170/176
- Catalog Number
- 4120
- 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
- 452c97d3-94c5-442c-af64-b995307b1c86
- Distribution End Date
- 2026-12-31
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.
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 | 07350078441902 | GS1 |