Identity
- Trade Name
- Primo Ferro FDA UDI
- Generic Name
- Hydrotherapy bath/tank FDA UDI
- Device Name
- Bath System - Primo Ferro, Sys23, Hydromass. FDA UDI
- Model / Reference
- AS32312-US FDA UDI
- Description
- Bath System - Primo Ferro, Sys23, Hydromass. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055982744812 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 e02861e3-2832-4a53-90f5-68691cf6ede5 33 fields · synced May 31, 2026