Identity
- Trade Name
- Wenzelite FDA UDI
- Generic Name
- Bath back rest/seat FDA UDI
- Device Name
- Wenzelite Bath chairs Product Description Otter Bath Chair w/Soft Fabic,Medium,1ea FDA UDI
- Model / Reference
- OT 2000 SF FDA UDI
- Description
- Wenzelite Bath chairs Product Description Otter Bath Chair w/Soft Fabic,Medium,1ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383253466 FDA UDI
- FDA Product Code
- ILS FDA UDI
- GMDN Term
- Bath back rest/seat FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Wenzelite by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI ca5434df-677e-46bd-a207-a3776e2e67d4 34 fields · synced Jun 8, 2026