Identity
- Trade Name
- iHealth FDA UDI
- Generic Name
- Hydrotherapy solute FDA UDI
- Model / Reference
- 3.6g*90 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850044118847 FDA UDI
- FDA Product Code
- KMA FDA UDI
- GMDN Term
- Hydrotherapy solute FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5550 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hydrotherapy solute
iHealth by Ihealth Lab Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ihealth Lab Inc.
Sources (1)
- FDA UDI 2a58a97b-0d01-454c-9437-2b2b36c9aa1e 32 fields · synced Jun 1, 2026