Identity
- Trade Name
- Aeda FDA UDI
- Generic Name
- Alternating-pressure bed mattress overlay system FDA UDI
- Device Name
- This medical device is an Air Mattress, it is consist of a series of air cells which is used to support the patient when inflated, it is always used with an Air Pump, which is used to control the Air Mattress Cells (air cells) to be inflated and deflated alternatively with a setting cycle time, and keep the Air Cells in a setting pressure value. FDA UDI
- Model / Reference
- 3M01M060023 FDA UDI
- Description
- This medical device is an Air Mattress, it is consist of a series of air cells which is used to support the patient when inflated, it is always used with an Air Pump, which is used to control the Air Mattress Cells (air cells) to be inflated and deflated alternatively with a setting cycle time, and keep the Air Cells in a setting pressure value. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897079030078 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Alternating-pressure bed mattress overlay system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alternating-pressure bed mattress overlay system
Aeda by Aeda Healthcare Limited — 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
- Aeda Healthcare Limited
Sources (1)
- FDA UDI 6f724d49-1f6c-4ddd-a5c9-343dedfad63c 34 fields · synced May 30, 2026