FDA UDI
In Commercial Distribution
🇺🇸 United States
Wicked Smart
DI: 00856455007428
·
Model: Version 1
·
Wicked Sheets, LLC
Product Codes
1
GMDN Terms
1
Identifiers
14
Pkg Device Count
1
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Basic Information
- Brand Name
- Wicked Smart
- Primary DI
- 00856455007428
- Version / Model
- Version 1
- Company Name
- Wicked Sheets, LLC
- Labeler DUNS
- 017805579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-19
- Public Version
- 4
- Public Version Date
- 2026-04-22
- Public Version Status
- Update
- Public Device Record Key
- 131c628d-3f04-4886-bd20-351ef37ef56c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- 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 | 00856455007428 | GS1 | ||||
| Package | 10856455007425 | GS1 | WSP Kit 5x | 1 | In Commercial Distribution | |
| Package | 20856455007422 | GS1 | Wicked Smart Module | 1 | In Commercial Distribution | |
| Package | 30856455007429 | GS1 | WSP Kit 4x | 1 | In Commercial Distribution | |
| Package | 40856455007426 | GS1 | WSP Kit 3x | 1 | In Commercial Distribution | |
| Package | 50856455007423 | GS1 | Pad - Single Ship | 1 | In Commercial Distribution | |
| Package | 60856455007420 | GS1 | BL - Single Ship | 1 | In Commercial Distribution | |
| Package | 70856455007427 | GS1 | Power Cord - Single | 1 | In Commercial Distribution | |
| Package | 80856455007424 | GS1 | Audio Jack - Single | 1 | In Commercial Distribution | |
| Package | 00856455007435 | GS1 | Power Supply-Single | 1 | In Commercial Distribution | |
| Package | 00856455007442 | GS1 | Audio Jack - 10 pack | 10 | In Commercial Distribution | |
| Package | 00856455007459 | GS1 | Power Cord - 5 pack | 5 | In Commercial Distribution | |
| Package | 00856455007466 | GS1 | WSP Kit 2x | 1 | In Commercial Distribution | |
| Package | 00856455007473 | GS1 | WSP Kit 1x | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 18889779881
- [email protected]