Identity
- Trade Name
- Primo Ferro FDA UDI
- Generic Name
- Hydrotherapy bath/tank FDA UDI
- Device Name
- Bath System - Ferro Sys23 HS P300 Disp Des FDA UDI
- Model / Reference
- AS33312US0010 FDA UDI
- Description
- Bath System - Ferro Sys23 HS P300 Disp Des FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982739122 FDA UDI
- FDA Product Code
- ILJ FDA UDI
- GMDN Term
- Hydrotherapy bath/tank FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5100 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
Yes
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
Category: Hydrotherapy bath/tank
Primo Ferro by Arjohuntleigh, Inc. — 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
- Arjohuntleigh, Inc.
Sources (1)
- FDA UDI 2f6f3ed1-ff89-42f9-9949-5904a4a51842 33 fields · synced May 31, 2026