Identity
- Trade Name
- Soteria Bed Barrier FDA UDI
- Generic Name
- Waterproof bed mattress cover, reusable FDA UDI
- Model / Reference
- Affinity Therapy Foot V AFTHPV-000F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850045714215 FDA UDI
- 510(k) Number
- K201876 FDA UDI
- FDA Product Code
- QTV FDA UDI
- GMDN Term
- Waterproof bed mattress cover, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6190 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Waterproof bed mattress cover, reusable
Soteria Bed Barrier by Trinity Guardion — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201876 also covers:
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
- Soteria Bed Barrier — Trinity Guardion
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 I | Pending data |
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Manufacturer
- Manufacturer
- Trinity Guardion
Sources (1)
- FDA UDI 528d3d0d-b15d-4358-ad36-cd11644c6595 34 fields · synced May 30, 2026