Identity
- Trade Name
- Mabis FDA UDI
- Generic Name
- Home-use facial steamer FDA UDI
- Device Name
- Steam Inhaler w/Facial Mask FDA UDI
- Model / Reference
- 40-742-000 FDA UDI
- Description
- Steam Inhaler w/Facial Mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00767056181212 FDA UDI
- FDA Product Code
- KFZ FDA UDI
- GMDN Term
- Home-use facial steamer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5460 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home-use facial steamer
Mabis by Dms Holdings, Inc., — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use facial steamer.
- Rite Aid — RITE AID CORPORATION · Class I
- Beurer — BEURER NORTH AMERICA, L.P. · Class I
- Mabis — DMS HOLDINGS, INC., · Class I
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
- Dms Holdings, Inc.,
Sources (1)
- FDA UDI dfc1f5e6-4376-44ee-8edf-55285ccb4035 33 fields · synced May 30, 2026