FDA UDI
In Commercial Distribution
🇺🇸 United States
Pjama
DI: 07350078441193
·
Model: Pjama Treatment Shorts Grey Age 10-12 - 146/152
·
Pjama AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pjama
- Primary DI
- 07350078441193
- Version / Model
- Pjama Treatment Shorts Grey Age 10-12 - 146/152
- Catalog Number
- 9020
- 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
- 1965ef3f-dfff-4f82-9b66-33a53388a1eb
- Distribution End Date
- 2026-12-31
Device Description
Pjama Bedwetting Treatment Pants / Shorts, an exceptional solution for those seeking a comprehensive answer to bedwetting challenges. These pants/shorts not only keep the bed dry throughout the night but also feature integrated sensor threads. Easily connect the Pjama Bedwetting Alarm (not included) for effective treatment. Crafted from the soft and breathable Tencel material, these treatment pants boast a waterproof membrane and super-absorbent fabric. This unique combination ensures that urine is contained within the pants, maintaining a dry bed.
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 | 07350078441193 | GS1 |