FDA UDI
In Commercial Distribution
🇺🇸 United States
Pjama
DI: 07350078440349
·
Model: Pjama Bedwetting Shorts Blue Age 8-10 - 134/140
·
Pjama AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pjama
- Primary DI
- 07350078440349
- Version / Model
- Pjama Bedwetting Shorts Blue Age 8-10 - 134/140
- Catalog Number
- 2026
- 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
- 7ce35f71-e579-4213-8b87-32531de8d43a
- Distribution End Date
- 2026-12-31
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.
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 |
|---|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | 876.5920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35120 | Incontinence pants, reusable | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350078440349 | GS1 |