Identity
- Trade Name
- Fresenius Medical Care FDA UDI
- Generic Name
- General examination/treatment chair, electric FDA UDI
- Device Name
- Electric treatment chair for use in dialysis, day surgery and oncology applications designed to accommodate bariatric patients. The chair can be used for patients up to weight not exceeding 300kg ( 660 lb). FDA UDI
- Model / Reference
- T600B FDA UDI
- Description
- Electric treatment chair for use in dialysis, day surgery and oncology applications designed to accommodate bariatric patients. The chair can be used for patients up to weight not exceeding 300kg ( 660 lb). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052882002883 FDA UDI
- 510(k) Number
- K091727 FDA UDI
- FDA Product Code
- INO FDA UDI
- GMDN Term
- General examination/treatment chair, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3110 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Fresenius Medical Care by Fresenius Medical Care Seating (australia) Pty Ltd — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Seating (australia) Pty Ltd
Sources (1)
- FDA UDI 8a8b8bdb-036e-4bd1-90a5-550b0f41648b 35 fields · synced Jun 8, 2026