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. The chair is intended for patients with weight not exceeding 441 lbs (200kg) FDA UDI
- Model / Reference
- T588 FDA UDI
- Description
- Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair is intended for patients with weight not exceeding 441 lbs (200kg) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052882003651 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
- 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
Yes
FDA UDI
Category: General examination/treatment chair, electric
Fresenius Medical Care by Fresenius Medical Care Seating (australia) Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 faf71d01-e670-4637-bad8-6462bc2b5e54 33 fields · synced May 30, 2026