Identity
- Trade Name
- DRIVEMEDICAL FDA UDI
- Generic Name
- Sitz bath kit, reusable FDA UDI
- Device Name
- Personal CareAids to Daily Living Product Description: Sitz Bath,1EA,6/CS FDA UDI
- Model / Reference
- SF8010 FDA UDI
- Description
- Personal CareAids to Daily Living Product Description: Sitz Bath,1EA,6/CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383121383 FDA UDI
- FDA Product Code
- KTC FDA UDI
- GMDN Term
- Sitz bath kit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5125 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sitz bath kit, reusable
Drivemedical by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sitz bath kit, reusable.
- BIOS Living — Thermor Ltd · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Drive — Drive Devilbiss Healthcare · Class I
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 3574284f-6da2-47bc-a784-9b993fe4a0e5 33 fields · synced Jun 8, 2026