Identity
- Trade Name
- AIR-MATT FDA UDI
- Generic Name
- Patient transfer system, powered FDA UDI
- Device Name
- AIR-MATT 34"/86CM X 48"/122CM LONG SPU SHORT FDA UDI
- Model / Reference
- AM34DSE FDA UDI
- Description
- AIR-MATT 34"/86CM X 48"/122CM LONG SPU SHORT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854564008213 FDA UDI
- FDA Product Code
- FMR FDA UDI
- GMDN Term
- Patient transfer system, powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6785 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
Yes
FDA UDI
MR Safe FDA UDI
Category: Patient transfer system, powered
Air-Matt by Air-Matt Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Single Patient Use HoverMatt — Hovertech International · Class II
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- HoverMatt SPU Plus HoverCover — Hovertech International · Class II
- Sprint 200 — L I N E T spol. s r.o. · Class II
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
- Air-Matt Incorporated
Sources (1)
- FDA UDI 66ace824-9092-4059-9a65-ea6f40214339 34 fields · synced May 29, 2026