Identity
- Trade Name
- Shield FDA UDI
- Generic Name
- Incontinence sensor/alarm FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- TSM45G FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854950002283 FDA UDI
- FDA Product Code
- KPN FDA UDI
- GMDN Term
- Incontinence sensor/alarm FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.2040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Incontinence sensor/alarm
Shield by Theos Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Incontinence sensor/alarm.
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- Malem — MALEM MEDICAL LIMITED · Class II
- SIM sensor LIGHT kit — SIMAVITA (AUST) PTY LTD · Class II
- SIM assess sensor pad Heavy — SIMAVITA (AUST) PTY LTD · Class II
- SIM™ assist — SIMAVITA (AUST) PTY LTD · Class II
- SIM™ tablet accessories — SIMAVITA (AUST) PTY LTD · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Theos Medical Systems, Inc.
Sources (1)
- FDA UDI ce719cb2-7f24-4a93-8abc-58474fd221d7 33 fields · synced May 30, 2026